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Trial record 2 of 9 for:    EVEREST II

Real World Expanded Multi-center Study of the MitraClip System (REALISM)

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01931956
First received: August 27, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

Prospective, multi-center, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Clinical follow-up at discharge, 30 days, 6 months, 12 months, and 2-, 3-, 4-, and 5-years. The study consists of two arms: a high risk group and a non-high risk group. Enrollment in high risk arm is ongoing. Enrollment in non-high risk arm concluded in April 2011.


Condition Intervention
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Device: MitraClip

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multi-center Study of the MitraClip System (REALISM)

Further study details as provided by Evalve:

Intervention Details:
    Device: MitraClip
    Percutaneous mitral valve repair using MitraClip implant
Detailed Description:

The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's System (MitraClip device). After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) and EVEREST II High Risk Registry Study (HRR), continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm is ongoing.

REALISM is a prospective, multi-center, 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). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

Candidates for the non-high risk arm must meet all of the following Inclusion criteria:

  • Age 18 years or older.
  • Moderate to severe (3+) or severe (4+) chronic mitral valve regurgitation and:

    1. Symptomatic with > 25% left ventricular ejection fraction (LVEF) and Left ventricular end systolic dimension (LVESD) ≤ 55mm or,
    2. Asymptomatic with one or more of the following:

    i. LVEF 25% to 60% ii. LVESD ≥ 40 mm iii. New onset of atrial fibrillation iv. Pulmonary hypertension defined as pulmonary artery systolic pressure (PASP) >50mmHg at rest or >60mmHg with exercise.

  • Candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass.
  • The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve. If a secondary jet exists, it must be considered clinically insignificant.
  • Male or non-pregnant female (confirmed by negative serum pregnancy test within 7 days prior to procedure).
  • The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
  • Trans-septal catheterization is determined to be feasible by the treating physician.

Candidates for the high risk arm must meet all of the following Inclusion criteria:

  • Predicted procedural mortality risk calculated using the Society for Thoracic Surgeons (STS) surgical risk calculator of ≥ 12% or in the judgment of a cardiac surgeon the patient is considered a high risk surgical candidate due to the presence of one of the following indications:

    1. Porcelain aorta or mobile ascending aortic atheroma
    2. Post-radiation mediastinum
    3. Previous mediastinitis
    4. Functional MR with EF<40
    5. Over 75 years old with EF<40
    6. Re-operation with patent grafts
    7. Two or more prior chest surgeries
    8. Hepatic cirrhosis
    9. Three (3) or more of the following STS high risk factors

    i. Creatinine > 2.5 mg/dL ii. Prior chest surgery iii. Age over 75 iv. EF<35

  • Age 18 years or older.
  • Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Attachment A.
  • American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower.
  • The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve.
  • Male or non-pregnant female.
  • The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
  • Transseptal catheterization is determined to be feasible by the treating physician.

Exclusion Criteria

Candidates will be excluded from the non-high risk arm of the study if any of the following conditions are present:

  • Evidence of an acute myocardial infarction in the prior 12 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥2X the upper laboratory normal limit with the presence of a creatine kinase MB isoenzyme (CK-MB) elevated above the institution's upper limit of normal).
  • The need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid valve disease.
  • Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure.
  • In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present.
  • Severe left ventricular dysfunction, defined as an ejection
  • Mitral valve orifice area <4.0 cm2.
  • If leaflet flail is present

    1. Flail Width: the width of the flail segment is greater than or equal to 15 mm, or
    2. Flail Gap: the flail gap is greater than or equal to 10 mm.
  • If leaflet tethering is present:

    a. Coaptation Length: the vertical coaptation length is less than 2 mm.

  • Severe mitral annular calcification.
  • Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:

    1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
    2. Presence of a significant cleft of A2 or P2 scallops
    3. More than one anatomic criteria dimensionally near the exclusion limits
    4. Bileaflet flail or severe bileaflet prolapse
    5. Lack of both primary and secondary chordal support
  • Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.
  • Need for emergency surgery for any reason.
  • Prior mitral valve surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted ventricular assist device (VAD).
  • Systolic anterior motion of the mitral valve leaflet.
  • Hypertrophic cardiomyopathy.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated).
  • History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months.
  • Upper GI bleeding within the prior 6 months.
  • History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
  • Concurrent medical condition with a life expectancy of less than 12 months (please refer to definition in Section 7).
  • A platelet count <75,000 cells/mm³.
  • Renal insufficiency (Creatinine >2.5mg/dL).
  • Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
  • Intravenous drug abuse or suspected inability to adhere to followup.
  • Patients in whom transesophageal echocardiography (TEE) is contraindicated.
  • A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
  • In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials].

Candidates will be excluded from the high risk arm of the study if any of the following conditions are present:

  • Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes ≥ 2X the upper laboratory normal limit with the presence of a CK-MB elevated above the institution's upper limit of normal).
  • In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
  • Ejection fraction < 20%, and/or end-systolic dimension > 60 mm.
  • Mitral valve orifice area < 4.0 cm2.
  • If leaflet flail is present:

    1. Flail Width: the width of the flail segment is greater than or equal to 15 mm
    2. Flail Gap: the flail gap is greater than or equal to 10 mm
  • If leaflet tethering is present, Coaptation Length: the vertical coaptation length is less than 2 mm.
  • Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:

    1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
    2. Presence of a significant cleft of A2 or P2 scallops
    3. More than one anatomic criteria dimensionally near the exclusion limits
    4. Bileaflet flail or severe bileaflet prolapse
    5. Lack of both primary and secondary chordal support
  • Hemodynamic instability defined as systolic pressure < 90 mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.
  • Need for emergent or urgent surgery for any reason.
  • Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased (i.e. noncompliant, perforated).
  • History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
  • Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
  • Intravenous drug abuse or suspected inability to adhere to followup.
  • Patients in whom transesophageal echocardiography (TEE) is contraindicated.
  • A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
  • In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials].
  • Any medical condition(s) that in the opinion of the investigator is likely to result in death within 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931956

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Baptist Hospital of Miami, FL
Miami, Florida, United States, 33176
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Evalve
Investigators
Study Director: Ted Feldman, M.D. Feldman, M.D. NorthShore University HealthSystem
Study Director: Donald D Glower Jr., MD Duke University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01931956     History of Changes
Other Study ID Numbers: 0401B, 0401
Study First Received: August 27, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Evalve:
EVEREST
EVEREST I
EVEREST II
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
MR
Mitral Valve Prolapse
E2E - Edge to Edge
Alfieri Technique
MitraClip
Functional MR
Degenerative MR
Echocardiogram
CAD - Coronary Artery Disease
Heart Failure
Heart Attack
REALISM

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on November 25, 2014