Trial Search Results
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation
Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 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, 6 months, and annually through 5 years.
Stanford is currently accepting patients for this trial.
- Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
- Device: Surgical Mitral Valve Replacement (SMVR)
- moderate to severe or severe symptomatic mitral regurgitation
- candidate for bioprosthetic mitral valve replacement, as determined by heart team
- prior transcatheter mitral valve procedure with device currently implanted
- anatomic contraindications
- prohibitive mitral annular calcification
- left ventricular ejection fraction <25%
- need for emergent or urgent surgery
- hemodynamic instability
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study