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

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)