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The ENCIRCLE Trial (ENCIRCLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153292
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Valve Insufficiency Device: SAPIEN M3 valve and dock Not Applicable

Detailed Description:
This is a prospective single-arm, multicenter study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: TMVR - Main Cohort
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
 Device: SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Experimental: TMVR - Failed TEER Registry
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
 Device: SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Experimental: TMVR - MAC Registry
Subjects with mitral annular calcification (MAC) will have TMVR.
 Device: SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.


Outcome Measures
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Primary Outcome Measures :
  1. Non-hierarchical composite of death and heart failure rehospitalization [ Time Frame: 1 year ]
    Number of subjects with death and/or heart failure rehospitalization


Secondary Outcome Measures :
  1. Improvement in NYHA functional class compared to baseline [ Time Frame: 1 year ]
    New York Heart Association (NYHA) functional classification of heart failure is based on how much a patient is limited during physical activity. The rating ranges from I-IV. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest.

  2. Improvement in KCCQ Overall Score compared to baseline [ Time Frame: 1 year ]
    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  3. Improvement in MR compared to baseline [ Time Frame: 1 year ]
    Number of subjects with improved MR compared to baseline

  4. Decrease in LVEDVi compared to baseline [ Time Frame: 1 year ]
    Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline


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

Inclusion Criteria:

  1. 18 years of age or older
  2. MR ≥ 3+
  3. NYHA functional class ≥ II
  4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
  5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
  6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
  2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
  3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
  4. Left ventricular ejection fraction <25%
  5. Severe right ventricular dysfunction
  6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
  7. History of heart transplant
  8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  9. Active bacterial endocarditis within 180 days of the procedure
  10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
  11. Myocardial infarction within 30 days of the procedure
  12. Clinically significant untreated coronary artery disease requiring revascularization
  13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
  14. Stroke or transient ischemic attack within 90 days of the procedure
  15. Irreversible, severe pulmonary hypertension
  16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
  17. Renal insufficiency or receiving renal replacement therapy
  18. Liver disease
  19. Planned surgery within the next 12 months
  20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
  21. Active infection requiring current antibiotic therapy
  22. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  24. Refusal of blood products
  25. Female who is pregnant or lactating
  26. Estimated life expectancy <12 months due to non-cardiac conditions
  27. Participating in another investigational drug or device study that has not reached its primary endpoint
  28. Subject considered to be part of a vulnerable population
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153292


Contacts
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Contact: Edwards THV Clinical Affairs +1 (949) 250-2500 THV_CT.gov@Edwards.com

Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: John Webb, MD St. Paul's Hospital
Principal Investigator: Mayra Guerrero, MD Mayo Clinic
Principal Investigator: David Daniels, MD California Pacific Medical Center
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04153292    
Other Study ID Numbers: 2018-19
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases