Pivotal Study of a Percutaneous Mitral Valve Repair System (EVERESTIIRCT)

• ClinicalTrials.gov Identifier: NCT00209274
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Results First Posted: September 5, 2017
• Last Update Posted: November 7, 2018
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

Condition or disease	Intervention/treatment	Phase
Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency	Device: Percutaneous mitral valve repair using MitraClip implant; Procedure: Mitral valve repair or replacement surgery	Not Applicable

Detailed Description:

Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).

A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 279 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
• Study Start Date: August 2005
• Actual Primary Completion Date: November 2009
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm	Device: Percutaneous mitral valve repair using MitraClip implant; MitraClip Implant; Other Name: MitraClip
Active Comparator: 2; Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.	Procedure: Mitral valve repair or replacement surgery; Repair or replacement of mitral valve

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Major Adverse Events (MAE) [ Time Frame: 30 days ]
   Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
2. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Freedom From All-Cause Mortality [ Time Frame: 12 months ]
2. Freedom From All-Cause Mortality [ Time Frame: 24 months ]
3. Freedom From All-Cause Mortality [ Time Frame: 3 years ]
4. Freedom From All-Cause Mortality [ Time Frame: 4 years ]
5. Freedom From All-Cause Mortality [ Time Frame: 5 years ]
6. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation. [ Time Frame: 12 months ]
7. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). [ Time Frame: 24 months ]
8. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort [ Time Frame: 24 months ]
9. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: At discharge (≤ 14 days following index procedure) or 30 days ]
   LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
10. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 12 months ]
    LVEF as determined by the core echo laboratory.
11. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 24 months ]
    LVEF as determined by the core echo laboratory.
12. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 3 years ]
    LVEF as determined by the core echo laboratory.
13. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 4 years ]
    LVEF as determined by the core echo laboratory.
14. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 5 years ]
    LVEF as determined by the core echo laboratory.
15. Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) [ Time Frame: 30 days ]
    Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
16. Left Ventricular Status- LVEDV, LVESV [ Time Frame: 12 months ]
    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
17. Left Ventricular Status- LVEDV, LVESV [ Time Frame: 24 months ]
    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
18. Left Ventricular Status- LVEDV, LVESV [ Time Frame: 3 years ]
    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
19. Left Ventricular Status- LVEDV, LVESV [ Time Frame: 4 years ]
    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
20. Left Ventricular Status- LVEDV, LVESV [ Time Frame: 5 years ]
    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
21. Left Ventricular Internal Dimension Systole (LVIDs) [ Time Frame: 30 days ]
    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
22. Left Ventricular Internal Dimension Systole (LVIDs) [ Time Frame: 12 months ]
    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
23. Left Ventricular Internal Dimension Systole (LVIDs) [ Time Frame: 2 years ]
    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
24. Left Ventricular Internal Dimension Systole (LVIDs) [ Time Frame: 3 years ]
    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
25. Left Ventricular Internal Dimension Systole (LVIDs) [ Time Frame: 4 years ]
    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
26. Left Ventricular Internal Dimension Systole (LVIDs) [ Time Frame: 5 years ]
    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
27. Left Ventricular Internal Dimension Diastole (LVIDd) [ Time Frame: 30 days ]
    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
28. Left Ventricular Internal Dimension Diastole (LVIDd) [ Time Frame: 12 months ]
    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
29. Left Ventricular Internal Dimension Diastole (LVIDd) [ Time Frame: 24 months ]
    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
30. Left Ventricular Internal Dimension Diastole (LVIDd) [ Time Frame: 3 years ]
    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
31. Left Ventricular Internal Dimension Diastole (LVIDd) [ Time Frame: 4 years ]
    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
32. Left Ventricular Internal Dimension Diastole (LVIDd) [ Time Frame: 5 years ]
    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
33. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: Baseline ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

34. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: 30 days ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

35. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: 12 months ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

36. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: 24 months ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

37. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: 3 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

38. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: 4 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

39. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [ Time Frame: 5 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

40. New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [ Time Frame: 30 days ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

41. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [ Time Frame: 12 months ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

42. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [ Time Frame: 2 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

43. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [ Time Frame: 3 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

44. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [ Time Frame: 4 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

45. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [ Time Frame: 5 years ]

    Class I: Patients with cardiac disease but without resulting limitations of physical activity.

    Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

    Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

46. Short Form (SF)-36 Quality of Life Questionnaire. [ Time Frame: 30 days ]

    The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

    The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

47. Short Form (SF)-36 Quality of Life Questionnaire. [ Time Frame: 12 months ]

    The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

    The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

48. Cardiac Output [ Time Frame: 30 days ]
    Cardiac output as measured by core lab echocardiography.
49. Cardiac Output [ Time Frame: 12 months ]
    Cardiac output as measured by core lab echocardiography.
50. Cardiac Output [ Time Frame: 24 months ]
    Cardiac output as measured by core lab echocardiography.
51. Cardiac Index [ Time Frame: 30 days ]
    Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
52. Cardiac Index (CI) [ Time Frame: 12 months ]
    Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
53. Cardiac Index [ Time Frame: 24 months ]
    Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
54. Regurgitant Volume [ Time Frame: 30 Days ]
    Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
55. Regurgitant Volume [ Time Frame: 12 months ]
    Regurgitant volume as determined by the core echo laboratory.
56. Regurgitant Volume [ Time Frame: 24 months ]
    Regurgitant volume as determined by the core echo laboratory.
57. Regurgitant Fraction (RF) [ Time Frame: 30 Days ]
    RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
58. Regurgitant Fraction [ Time Frame: 12 months ]
    Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
59. Regurgitant Fraction [ Time Frame: 24 months ]
    Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
60. Number of Participants With Clip Implant Rate [ Time Frame: Day 0 ]
    Defined as the rate of successful implantation of MitraClip(s).
61. Number of Participants With Acute Procedural Success [ Time Frame: 30 Days ]
    Defined as successful MitraClip implantation with resulting MR of 2+ or less.
62. Number of Participants With Acute Surgical Success [ Time Frame: 30 Days ]
    Defined as successful mitral valve repair or replacement surgery.
63. Number of Participants With Successful Clip Implant and Acute Procedural Success [ Time Frame: 30 days ]
    Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
64. Number of Participants With Mitral Valve Repair Success. [ Time Frame: 12 months ]
    Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
65. Number of Participants With Mitral Valve Repair Success. [ Time Frame: 24 months ]
    Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
66. Number of Participants With Procedural Freedom From In-hospital MAE. [ Time Frame: Day 0 ]
67. Number of Participants With Procedural Freedom From In-hospital MAE [ Time Frame: Day 30 ]
68. Number of Participants With MAE: Surgery After Device and First Time Surgery Control [ Time Frame: 30 days ]
69. Number of Participants With Major Vascular Complications [ Time Frame: 30 days ]

    Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:

    • Hematoma at access site >6 cm;
    • Retroperitoneal hematoma;
    • Arteriovenous (AV) fistula;
    • Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
    • Vascular Surgical Repair at catheter access sites;
    • Pulmonary embolism;
    • Ipsilateral deep vein thrombus; or
    • Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
70. Number of Participants With Major Vascular Complications [ Time Frame: 12 months ]

    Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:

    • Hematoma at access site >6 cm;
    • Retroperitoneal hematoma;
    • Arteriovenous (AV) fistula;
    • Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
    • Vascular Surgical Repair at catheter access sites;
    • Pulmonary embolism;
    • Ipsilateral deep vein thrombus; or
    • Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
71. Number of Participants With Major Bleeding Complications. [ Time Frame: 30 days ]
    Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
72. Number of Participants With Major Bleeding Complications. [ Time Frame: 12 months ]
    Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.
73. Number of Participants With Major Adverse Events (MAE) [ Time Frame: 12 months. ]
74. Number of Participants With MAE in Patients Over 75 Years of Age. [ Time Frame: 30 days ]
75. Number of Participants With MAE in Patients Over 75 Years of Age. [ Time Frame: 12 months ]
76. Number of Participants With Dysrhythmia [ Time Frame: 30 days ]
77. Number of Participants With Dysrhythmia [ Time Frame: 12 months ]
78. Number of Participants With Endocarditis. [ Time Frame: 30 days ]
    Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
79. Number of Participants With Endocarditis. [ Time Frame: 12 months ]
    Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
80. Number of Participants With Thrombosis. [ Time Frame: 30 days ]
    Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
81. Number of Participants With Thrombosis. [ Time Frame: 12 months ]
    Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
82. Number of Participants With Hemolysis [ Time Frame: 30 days ]

    Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:

    Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.

    Minor: Does not require intervention.

83. Number of Participants With Hemolysis [ Time Frame: 12 months ]

    Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:

    Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.

    Minor: Does not require intervention.

84. Number of Participants With Clinically Significant Atrial Septal Defect (ASD). [ Time Frame: 30 days ]
    Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
85. Number of Participants With Clinically Significant Atrial Septal Defect (ASD) [ Time Frame: 12 months ]
    Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
86. Number of Participants With Mitral Valve Stenosis [ Time Frame: 30 days ]
    Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
87. Number of Participants With Mitral Valve Stenosis [ Time Frame: 12 months ]
    Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
88. Number of Participants With Mitral Valve Stenosis [ Time Frame: 24 months ]
    Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
89. Number of Participants With Mitral Valve Stenosis [ Time Frame: 3 years ]
    Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
90. Number of Participants With Mitral Valve Stenosis [ Time Frame: 4 years ]
    Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
91. Number of Participants With Mitral Valve Stenosis [ Time Frame: 5 years ]
    Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
92. Mitral Valve Area by Planimetry [ Time Frame: At Discharge (≤14 days of index procedure) ]
    Mitral valve area as measured by core lab echocardiography.
93. Mitral Valve Area by Planimetry [ Time Frame: 30 Days ]
    Mitral valve area as measured by core lab echocardiography.
94. Mitral Valve Area by Planimetry [ Time Frame: 12 months ]
    Mitral valve area as measured by core lab echocardiography.
95. Mitral Valve Area by Planimetry [ Time Frame: 24 months ]
    Mitral valve area as measured by core lab echocardiography.
96. Mitral Valve Area by Planimetry [ Time Frame: 3 years ]
    Mitral valve area as measured by core lab echocardiography.
97. Mitral Valve Area by Planimetry [ Time Frame: 4 years ]
    Mitral valve area as measured by core lab echocardiography.
98. Mitral Valve Area by Planimetry [ Time Frame: 5 years ]
    Mitral valve area as measured by core lab echocardiography.
99. Mitral Valve Area by Planimetry Index [ Time Frame: 30 Days ]
    Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
100. Mitral Valve Area by Planimetry Index [ Time Frame: 12 months ]
     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
101. Mitral Valve Area by Planimetry Index [ Time Frame: 24 months ]
     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
102. Mitral Valve Area by Pressure Half-time [ Time Frame: At Discharge (≤14 days of index procedure) ]
     Mitral valve area as measured by core lab echocardiography.
103. Mitral Valve Area by Pressure Half-time [ Time Frame: 30 days ]
     Mitral valve area as measured by core lab echocardiography.
104. Mitral Valve Area by Pressure Half-time [ Time Frame: 12 months ]
     Mitral valve area as measured by core lab echocardiography.
105. Mitral Valve Area by Pressure Half-time [ Time Frame: 24 months ]
     Mitral valve area as measured by core lab echocardiography.
106. Mitral Valve Area by Pressure Half-time [ Time Frame: 3 years ]
     Mitral valve area as measured by core lab echocardiography.
107. Mitral Valve Area by Pressure Half-time [ Time Frame: 4 years ]
     Mitral valve area as measured by core lab echocardiography.
108. Mitral Valve Area by Pressure Half-time [ Time Frame: 5 years ]
     Mitral valve area as measured by core lab echocardiography.
109. Mitral Valve Area by Pressure Half-time Index [ Time Frame: 30 Days ]
     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
110. Mitral Valve Area by Pressure Half-time Index [ Time Frame: 12 months ]
     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
111. Mitral Valve Area by Pressure Half-time Index [ Time Frame: 24 months ]
     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
112. Transvalvular Mitral Valve Gradient [ Time Frame: At Discharge (≤ 14 days following index procedure) ]
     Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
113. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [ Time Frame: 12 months ]
     Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
114. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [ Time Frame: 24 months ]
     Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
115. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [ Time Frame: 3 year ]
     Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
116. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [ Time Frame: 4 year ]
     Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
117. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [ Time Frame: 5 years ]
     Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
118. Post-procedure Length of Hospital Stay [ Time Frame: 30 Days ]
119. Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration [ Time Frame: 30 Days ]
120. Number of Participants With Hospital Re-admissions [ Time Frame: 30 days ]
     Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
121. Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital [ Time Frame: 30 Days ]
122. Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF). [ Time Frame: 30 days ]
123. Number of Participants With New Coumadin (Warfarin) Usage [ Time Frame: 30 days ]
124. Number of Participants With New Coumadin (Warfarin) Usage [ Time Frame: 12 months ]
125. Number of Participants With Durability of the MitraClip Device and Surgery. [ Time Frame: 12 months ]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

     Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

126. Number of Participants With Durability of the MitraClip Device and Surgery. [ Time Frame: 12-18 months ]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

     Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

127. Number of Participants With Durability of the MitraClip Device and Surgery. [ Time Frame: 18-24 months ]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

     Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

128. Number of Participants With Durability of the MitraClip Device and Surgery. [ Time Frame: 24 months-3 year ]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

     Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

129. Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ [ Time Frame: 12 months ]
     Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
130. Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ [ Time Frame: 24 months ]
     Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
131. Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ [ Time Frame: 3 years ]
     Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
132. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [ Time Frame: 12 months ]
     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
133. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [ Time Frame: 24 months ]
     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
134. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [ Time Frame: 3 years ]
     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
135. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [ Time Frame: 4 years ]
     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
136. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [ Time Frame: 5 years ]
     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
137. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [ Time Frame: 12 months ]
     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
138. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [ Time Frame: 24 months ]
     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
139. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [ Time Frame: 3 years ]
     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
140. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [ Time Frame: 4 years ]
     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
141. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [ Time Frame: 5 years ]
     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
142. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [ Time Frame: 12 months ]
     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
143. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [ Time Frame: 12 months to 3 years ]
     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
144. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [ Time Frame: 12 months to 4 years ]
     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
145. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [ Time Frame: 12 months to 5 years ]
     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
146. Number of Participants With Non-cerebral Thromboembolism. [ Time Frame: 12 months ]
     Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
147. Number of Participants With MR Severity [ Time Frame: 30 days ]

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

     "Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.

148. Number of Participants With MR Severity [ Time Frame: 12 months ]
     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
149. Number of Participants With MR Severity [ Time Frame: 24 months ]
     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
150. Number of Participants With MR Severity [ Time Frame: 3 years ]
     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
151. Number of Participants With MR Severity [ Time Frame: 4 years ]
     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
152. Number of Participants With MR Severity [ Time Frame: 5 years ]
     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
153. Number of Participants With Non-cerebral Thromboembolism. [ Time Frame: 30 days ]
     Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
154. Number of Participants With Incidence of Mitral Valve Replacement [ Time Frame: 12 months ]
155. Number of Participants With Incidence of Mitral Valve Replacement [ Time Frame: 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion/Exclusion Criteria:

Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:

• Are 18 years or older.
• Symptomatic
• If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
• Are candidates for mitral valve surgery
• Are candidates for transseptal catheterization
• Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
• Appropriate valve anatomy for MitraClip
• Does not need other cardiac surgery or any emergency surgery
• Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
• Mitral valve orifice area ≥ 4 cm2
• Do not have renal insufficiency
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation

Contacts and Locations

Locations

United States, Illinois

Evanston Northwestern Healthcare

Evanston, Illinois, United States, 60201

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Principal Investigator: Ted Feldman, M.D.; NorthShore University HealthSystem
• Principal Investigator: Donald G Glower Jr., MD; Duke University Medical Center, Department of Surgery

More Information

Publications of Results:

Dang NC, Aboodi MS, Sakaguchi T, Wasserman HS, Argenziano M, Cosgrove DM, Rosengart TK, Feldman T, Block PC, Oz MC. Surgical revision after percutaneous mitral valve repair with a clip: initial multicenter experience. Ann Thorac Surg. 2005 Dec;80(6):2338-42. doi: 10.1016/j.athoracsur.2005.05.030.

Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whitlow P, St Goar F, Rodriguez L, Silvestry F, Schwartz A, Sanborn TA, Condado JA, Foster E. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol. 2005 Dec 6;46(11):2134-40. doi: 10.1016/j.jacc.2005.07.065. Epub 2005 Oct 19.

Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8. doi: 10.1002/ccd.20917.

Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13.

Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.

Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.

Herrmann HC, Gertz ZM, Silvestry FE, Wiegers SE, Woo YJ, Hermiller J, Segar D, Heimansohn D, Gray W, Homma S, Argenziano M, Wang A, Jollis J, Lampert MB, Alexander J, Mauri L, Foster E, Glower D, Feldman T. Effects of atrial fibrillation on treatment of mitral regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized trial. J Am Coll Cardiol. 2012 Apr 3;59(14):1312-9. doi: 10.1016/j.jacc.2011.12.023.

Glower D, Ailawadi G, Argenziano M, Mack M, Trento A, Wang A, Lim DS, Gray W, Grayburn P, Dent J, Gillam L, Sethuraman B, Feldman T, Foster E, Mauri L, Kron I; EVEREST II Investigators. EVEREST II randomized clinical trial: predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure. J Thorac Cardiovasc Surg. 2012 Apr;143(4 Suppl):S60-3. doi: 10.1016/j.jtcvs.2012.01.047.

Smith T, McGinty P, Bommer W, Low RI, Lim S, Fail P, Rogers JH. Prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the MitraClip system. Catheter Cardiovasc Interv. 2012 Oct 1;80(4):678-85. doi: 10.1002/ccd.23485. Epub 2012 Mar 15.

Mauri L, Foster E, Glower DD, Apruzzese P, Massaro JM, Herrmann HC, Hermiller J, Gray W, Wang A, Pedersen WR, Bajwa T, Lasala J, Low R, Grayburn P, Feldman T; EVEREST II Investigators. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol. 2013 Jul 23;62(4):317-28. doi: 10.1016/j.jacc.2013.04.030. Epub 2013 May 9.

Foster E, Kwan D, Feldman T, Weissman NJ, Grayburn PA, Schwartz A, Rogers JH, Kar S, Rinaldi MJ, Fail PS, Hermiller J, Whitlow PL, Herrmann HC, Lim DS, Glower DD; EVEREST Investigators. Percutaneous mitral valve repair in the initial EVEREST cohort: evidence of reverse left ventricular remodeling. Circ Cardiovasc Imaging. 2013 Jul;6(4):522-30. doi: 10.1161/CIRCIMAGING.112.000098. Epub 2013 Apr 30.

Other Publications:

Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. doi: 10.1161/01.CIR.0000139855.12616.15. Epub 2004 Aug 9.

St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3. doi: 10.1161/01.CIR.0000096052.78331.CA. Epub 2003 Oct 6.

Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.

Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.

Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.

Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.

Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.

Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.

Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.

Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76.

Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.

Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.

Cikirikcioglu M, Cherian S, Schussler O, Kalangos A. Regarding "The EVEREST II Trial: design and rationale for a randomized study of the Evalve MitraClip system compared with mitral valve surgery for mitral regurgitation". Am Heart J. 2011 Jul;162(1):e11-2; author reply e13. doi: 10.1016/j.ahj.2011.04.004. Epub 2011 Jun 12. No abstract available.

Condado JA, Velez-Gimon M. Catheter-based approach to mitral regurgitation. J Interv Cardiol. 2003 Dec;16(6):523-34. doi: 10.1046/j.1540-8183.2003.01052.x.

Fann JI, St Goar FG. Percutaneous aortic valve replacement and mitral valve repair. Future Cardiol. 2005 May;1(3):393-403. doi: 10.1517/14796678.1.3.393.

Cohn LH. Percutaneous mitral valve repair with the edge-to-edge technique: a surgeon's perspective. J Am Coll Cardiol. 2005 Dec 6;46(11):2141-2. doi: 10.1016/j.jacc.2005.09.021. Epub 2005 Oct 17. No abstract available.

Condado JA, Acquatella H, Rodriguez L, Whitlow P, Velez-Gimo M, St Goar FG. Percutaneous edge-to-edge mitral valve repair: 2-year follow-up in the first human case. Catheter Cardiovasc Interv. 2006 Feb;67(2):323-5. doi: 10.1002/ccd.20603.

Feldman T, Glower D. Patient selection for percutaneous mitral valve repair: insight from early clinical trial applications. Nat Clin Pract Cardiovasc Med. 2008 Feb;5(2):84-90. doi: 10.1038/ncpcardio1068.

Biner S, Siegel RJ, Feldman T, Rafique AM, Trento A, Whitlow P, Rogers J, Moon M, Lindman B, Zajarias A, Glower D, Kar S; EVEREST investigators. Acute effect of percutaneous MitraClip therapy in patients with haemodynamic decompensation. Eur J Heart Fail. 2012 Aug;14(8):939-45. doi: 10.1093/eurjhf/hfs069. Epub 2012 May 14.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.

Gucuk Ipek E, Singh S, Viloria E, Feldman T, Grayburn P, Foster E, Qasim A. Impact of the MitraClip Procedure on Left Atrial Strain and Strain Rate. Circ Cardiovasc Imaging. 2018 Mar;11(3):e006553. doi: 10.1161/CIRCIMAGING.117.006553.

Feldman T, Kar S, Elmariah S, Smart SC, Trento A, Siegel RJ, Apruzzese P, Fail P, Rinaldi MJ, Smalling RW, Hermiller JB, Heimansohn D, Gray WA, Grayburn PA, Mack MJ, Lim DS, Ailawadi G, Herrmann HC, Acker MA, Silvestry FE, Foster E, Wang A, Glower DD, Mauri L; EVEREST II Investigators. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854. doi: 10.1016/j.jacc.2015.10.018.

Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.

Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.

Grayburn PA, Foster E, Sangli C, Weissman NJ, Massaro J, Glower DG, Feldman T, Mauri L. Relationship between the magnitude of reduction in mitral regurgitation severity and left ventricular and left atrial reverse remodeling after MitraClip therapy. Circulation. 2013 Oct 8;128(15):1667-74. doi: 10.1161/CIRCULATIONAHA.112.001039. Epub 2013 Sep 6.

Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043.

Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4. Erratum In: N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].

Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130. Epub 2011 Mar 21.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00209274
• Other Study ID Numbers: Protocol #0401; Protocol #0401
• First Posted: September 21, 2005
• Results First Posted: September 5, 2017
• Last Update Posted: November 7, 2018
• Last Verified: November 2018

Keywords provided by Abbott Medical Devices:

EVEREST; EVEREST I; EVEREST II; Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency; Mitral Valve; MR; Mitral Valve Prolapse; Edge to Edge (E2E); Alfieri Technique; MitraClip; Functional MR; Degenerative MR; Echocardiogram; CAD - Coronary Artery Disease; Heart Failure; Heart Attack; REALISM

Additional relevant MeSH terms:

Mitral Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases