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

Key Inclusion Criteria:

1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)
2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directedmedical therapy (GDMT) determined by the local multidisciplinary heart team
3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valvesurgery and not appropriate for commercially approved transcatheter mitral valvetherapies
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 allrequired post-procedure follow-up visits

Key Exclusion Criteria:

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 fortransfemoral access with the delivery system
3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, orvegetation
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 ofleft ventricular end diastolic volume index (LVEDVi) >120mL/m2 as measured by restingechocardiogram 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 systemicsystolic pressure
9. Right-sided congestive heart failure with echocardiographic evidence of severe rightventricular dysfunction
10. Severe tricuspid regurgitation
11. Prior mitral valve surgery or endovascular procedure, or need for other valvesurgery/procedure
12. Any endovascular therapeutic interventional or surgical procedure performed within 30days 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 ExpiratoryVolume (FEV1) < 750cc
17. Need for emergent surgery
18. Endocarditis within 6 months
19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulationtreatment
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 mechanicalcirculatory 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, patientsmay enroll 2 weeks after discontinuation of antibiotics)
26. Contraindication to transesophageal echocardiography (TEE)
27. Known hypersensitivity or contraindication to study or procedure medications/contrastwhich cannot be adequately managed medically
28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearingpotential must have a negative pregnancy test prior to enrollment)
29. Currently participating in an investigational drug or another device study that hasnot yet reached its primary endpoint