The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

Eligibility Criteria

• 1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)
• 2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team
• 3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies
• 4. Age ≥ 21
• 5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant
• 6. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
• 7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits
• 1. Prior transseptal intervention with occlusion device currently implanted
• 2. Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system
• 3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
• 4. Prohibitive mitral annular or leaflet calcification
• 5. Diseased mitral anterior leaflet such as flail or prolapse
• 6. Left ventricular ejection fraction (LVEF) \< 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) \>120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure
• 7. Left ventricular end diastolic diameter (LVEDD) \> 75mm
• 8. Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure
• 9. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
• 10. Severe tricuspid regurgitation
• 11. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
• 12. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
• 13. Prior stroke, TIA, or myocardial infarction within 90 days
• 14. Need for coronary revascularization
• 15. Severe symptomatic carotid artery stenosis
• 16. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc
• 17. Need for emergent surgery
• 18. Endocarditis within 6 months
• 19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment
• 20. GI bleeding within 6 months
• 21. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion
• 22. Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
• 23. Platelet count of \<75,000 cells/mm3
• 24. Renal insufficiency (Creatinine \> 2.5 mg/dL)
• 25. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
• 26. Contraindication to transesophageal echocardiography (TEE)
• 27. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
• 28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
• 29. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint