The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study
 (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with
 severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve
 surgery.
Key Inclusion 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

 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 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