Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy MItral Regurgitation who are Candidates for Surgery (REPAIR-MR)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Mitral Regurgitation
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subject has severe primary MR
    2. Subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ as confirmed by the study team
    3. Subjects are symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF = 60%, pulmonary artery pressure systolic pressure > 50 mmHg, or LVESD > 40 mm.
    4. Subject is at least 75 years of age. If younger than 75 years, then the subject should have:
      • Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score = 2% OR
      • Presence of other comorbidities which may introduce a potential surgeryspecific impediment.
    5. Subjects who can provide written informed consent

You may not be eligible for this study if the following are true:

    1. Subject who are currently participating in another clinical investigation
    2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate
    3. Subject’s mitral valve anatomy is such that it is not repairable by the cardiac surgeon
    4. Subject has ischemic or non-ischemic secondary MR
    5. Subject has valve anatomy which precludes the primary MitraClipTM device operator from reducing MR to mild or less
    6. Concomitant severe tricuspid valve regurgitation
    7. Ejection fraction <30%
    8. Severe mitral annular calcification
    9. Acute myocardial infarction in the past 12 weeks
    10. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease.
    11. Surgical procedure performed in the past 30 days
    12. Need for emergency surgery for any reason
    13. Hypertrophic cardiomyopathy
    14. Renal insufficiency
    15. Pregnant or planning to be pregnant

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