Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients with Severe Symptomatic Mitral Regurgitation - The Half Moon TMVr Pilot Study

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 21 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Moderately severe or severe mitral regurgitation (MR Grade = 3+)
    2. Symptomatic mitral regurgitation (NYHA Class II-IV)
    3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not optimal for commercially approved transcatheter mitral valve therapies
    4. Native mitral valve geometry and size compatible with the Half Moon TMVr implant
    5. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
    6. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits

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

    1. Prior transseptal intervention with occlusion device currently implanted
    2. Implanted with venous stents (iliac and femoral)
    3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
    4. Prohibitive mitral annular or leaflet calcification, or anterior leaflet flail or prolapse
    5. Left ventricular ejection fraction (LVEF) < 25%, or LVEF 25-30%
    6. Left ventricular end diastolic diameter (LVEDD) > 75mm
    7. Pulmonary hypertension
    8. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
    9. Severe tricuspid regurgitation
    10. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
    11. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
    12. Prior stroke, TIA, or myocardial infarction within 90 days
    13. Need for coronary revascularization
    14. Severe symptomatic carotid artery stenosis
    15. Severe Chronic Obstructive Pulmonary Disease (COPD)
    16. Need for emergent surgery
    17. Endocarditis within 6 months
    18. Participants unwilling or unable to adhere to the protocol recommended anticoagulation treatment
    19. GI bleeding within 6 months
    20. History of bleeding diathesis or coagulopathy or participant will refuse blood transfusion
    21. Hemodynamic instability
    22. Renal insufficiency
    23. Active infections requiring current antibiotic therapy
    24. Contraindication to transesophageal echocardiography (TEE)
    25. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
    26. Pregnant, nursing or planning to be pregnant
    27. Currently participating in an investigational drug or another device study

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