Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)
- Study HIC#:2000021883
- Last Updated:07/15/2021
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.
- Age18 years and older
- Start Date03/04/2018
- End Date10/30/2021
Trial Purpose and Description
Evaluate whether TMVR is non-inferior to conventional mitral surgery with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic native mitral regurgitation. Assess TMVR outcomes with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic mitral regurgitation.
- 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
- severe mitral annular calcification
- left ventricular ejection fraction <25>#/li###
- need for emergent or urgent surgery
- hemodynamic instability