SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Inclusion Criteria: 1. 18 years of age or older 2. MR ≥ 3+ 3. NYHA functional class ≥ II 4. High risk of cardiovascular surgery 5. Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve 2. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 3. Significant risk of LVOT obstruction 4. Severe right ventricular dysfunction 5. LV Ejection Fraction \<30% 6. Patient is inoperable 7. Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment 8. Need for aortic, tricuspid or pulmonic valve replacement 9. Presence of mechanical aortic valve prosthesis 10. History of cardiac transplantation 11. History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism 12. Clinically significant untreated coronary artery disease requiring revascularization 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days. 14. Stroke or transient ischemic attack within 90 days of the procedure 15. Myocardial infarction within 30 days of the procedure 16. Active bacterial endocarditis within 180 days of the procedure 17. Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy 18. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states 19. Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days. 20. Irreversible, severe pulmonary hypertension 21. Patients with renal insufficiency or receiving renal replacement therapy 22. Liver disease or significantly abnormal liver function test results 23. Refusal of blood products 24. Female who is pregnant or lactating 25. Estimated life expectancy \< 12 months 26. Participating in another investigational drug or device study