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

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