Cardiovalve Transfemoral System - FIM Study

Inclusion Criteria: * Age ≥ 18 years * NYHA functional II, III or ambulatory IV * Severe mitral regurgitation (MR grade 3-4+) * High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) * Able to undergo Transesophageal Echocardiography (TEE). * Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. * The subject commits to return for the scheduled post-operative follow-up visits at the hospital. * Suitable for femoral access procedure and transseptal catheterization * Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve Exclusion Criteria: * Prior stroke or TIA within 3 months * Acute myocardial infarction within the previous 30 days * Any prior heart valve surgery or transcatheter mitral intervention * Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days * Rheumatic heart disease or endocarditis within the previous 3 months * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology * Existence of inferior vena cava filter or atrial septal device (contr…