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 (contraindicating femoral access and transseptal catheterization) * Untreated clinically significant coronary artery disease requiring revascularization * Tricuspid valve disease requiring surgery or severe tricuspid regurgitation * Aortic valve disease requiring surgery Anatomical Exclusion Criteria (assessed by pre-procedural imaging) * Left Ventricular Ejection Fraction ( LVEF) \<30% * LV end diastolic diameter \> 70mm * Significant abnormalities of the mitral valve and sub-valvular apparatus. * Severe mitral annular or leaflets calcification * Left atrial or LV thrombus * Severe right ventricular dysfunction * Severe tricuspid or aortic valve disease General Exclusion Criteria * Subject who is currently participating in an investigational study, other than this study * Hemodynamic instability defined as systolic pressure \< 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance * Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications * Bleeding diathesis or hypercoagulable state * Active peptic ulcer or active gastrointestinal bleeding * Pulmonary artery systolic pressure \>70 mmHg * Patients with renal insufficiency (creatinine \> 2.5 mg/dL) * Subject with hepatic insufficiency * Subject has a co-morbid illness that may result in a life expectancy of less than one year * Active infection that requires antibiotic therapy * Subject is pregnant, breastfeeding or intend to become pregnant within one year