Research Study: INTREPID TMVR
severe, symptomatic mitral regurgitation
Study Sponsor: Medtronic Cardiovascular
Study Investigator: Vinayak Bapat, MD
Study Contact: Jenny Nguyen
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

PILOT: The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk mitral regurgitation patients. EFS: The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in patients with severe, symptomatic mitral regurgitation.
Eligibility Criteria:

Key Inclusion Criteria:

  • Severe mitral regurgitation (MR Grade 3-4+)
  • Symptomatic mitral regurgitation (NYHA Class II-IV)
  • Trans-apical access deemed feasible by the treating physician (PILOT only)
  • 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 Twelve TMVR/Intrepid

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!