Using the Medtronic Intrepid Transcatheter Mitral Valve Replacement System to Treat Severe Symptomatic Mitral Valve Leakage Mitral Regurgitation

What this Trial Is About

This trial evaluates the Medtronic Intrepid Transcatheter Mitral Valve Replacement System TMVR for patients with moderate to severe or severe symptomatic mitral valve regurgitation who are not suitable for approved transcatheter repair or conventional mitral valve surgery. It is a multi-center, global, prospective, non-randomized interventional study where all participants receive the study device. The trial is sponsored by Medtronic Cardiovascular and focuses on treatment outcomes with this device. Participants receive treatment with the Medtronic Intrepid TMVR device designed to replace the mitral valve via a catheter procedure. There are two experimental groups a primary cohort and a cohort with mitral annular calcification, both receiving the TMVR device. This is a single-group study without randomization or blinding, and treatment is delivered through the transcatheter valve replacement system. During the study, participants will be monitored over time with assessments including mortality, stroke, kidney injury, wound infection, reoperation, and bleeding within 30 days or hospital discharge. Additional measures include the degree of mitral regurgitation at 6 months, quality of life improvements at 3 months, heart function status at 30 days, echocardiographic evaluations at 1 year, and cardiovascular hospitalizations over 1 year. The primary outcome is evaluated at 1 year, with follow-up continuing up to the studys completion in 2036.

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.