Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation

PILOT: The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of The Intrepid™ TMVR System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery. EFS: The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation

Key Inclusion Criteria: * Severe mitral regurgitation (PILOT) * moderate-severe or severe mitral regurgitation (EFS) * Symptomatic mitral regurgitation (NYHA Class II-IV) * Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist) (PILOT and EFS) * Subjects anatomically suitable for the Intrepid TMVR delivery system, including transfemoral and transseptal access (EFS only) * Native mitral valve geometry and size compatible with the Intrepid™ TMVR (PILOT) Key Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \< 20 (PILOT) or \<30% (EFS) * Evidence of intracardiac mass, thrombus, or vegetation * Prior valve surgery or need for other valve surgery * Prior stroke within 30 days (PILOT) or 90 days (EFS) * Gastrointestinal bleeding within 6 months (PILOT) * Prior myocardial infarction 90 days (EFS) * Need for coronary revascularization * History of, or active, endocarditis if antibiotics are required (EFS) * Renal insufficiency; Serum Creatinine \> 2.5 mg/dL (PILOT) or Creatinine Clearance \<30 cc/min (EFS)