StudyFinder
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial
Recruiting
The purpose of this study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions. This system allows a bioprosthetic mitral valve (investigational valve) to be implanted through a long, thin, flexible tube that is inserted through an incision in the side of the chest or through an incision made in the groin area and through a vein in the leg. Participation in the study is expected to last approximately 5 years from the day the valve is implanted.
Male or Female
18 years and over
Inclusion Criteria:
• diagnosis of moderate or severe mitral value regurgitation with symptoms
• multidisciplinary heart team thinks patient is not able to have treatment an approved transcatheter repair or conventional mitral valve procedure
Exclusion Criteria:
• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
Heart & Vascular
Clinics and Surgery Center (CSC), Intrepid, Mitral valve, Mitral Valve Replacement, TAVR