Study ID: 3809
Transcatheter mitral valve replacement with the Medtronic Intrepid™ TMVR system in patients with severe symptomatic mitral regurgitation
Dubbed the APOLLO clinical trial, this is a pivotal study for patients diagnosed with a leakage of blood that moves backward through the mitral valve each time the left heart ventricle contracts. The trial is for patients who need their mitral valve replaced.
Patients will be randomized into one of two study arms. One group will have the TMVR system implanted in their mitral valve. The other group will undergo conventional surgical mitral valve replacement. Additionally, patients who are unable to undergo surgical replacement may qualify for the TMVR procedure.
This is a multi-center, global, prospective, interventional, pre-market trial with two subject groups randomized on a 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.
Subjects will be seen at pre- and post-procedure, discharge, 30 days, six months, and annually through five years.
- Patient must be deemed a candidate for bioprosthetic mitral valve replacement
- Must not have prohibitive mitral annular calcification or hemodynamic instability
- Must not have left ventricular ejection fraction <25%
- Must have been diagnosed with severe symptomatic mitral regurgitation
- Must agree to regular follow-up for up to five years