Active, currently enrolling
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
NCT No.: NCT03242642
Study Type: INTERVENTIONAL
Phase:
n/a
Region: California - Northern
Acronym: APOLLO
Official Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Purpose
This study is a 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.
Detailed Description
The purpose of this investigation is to evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation who are candidates for conventional mitral valve surgery. Medtronic Intrepid™ TMVR System is intended for use in patients with mitral regurgitation who are determined by a multidisciplinary heart team appropriate for trial participation based on the protocol specified Inclusion/Exclusion criteria.
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
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Severe, symptomatic mitral regurgitation
Candidate for bioprosthetic mitral valve replacement, as determined by heart team
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Exclusion Criteria
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Prior transcatheter mitral valve procedure with device currently implanted
Anatomic contraindications
Severe mitral annular calcification
Left ventricular ejection fraction <25%
Need for emergent or urgent surgery
Hemodynamic instability
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Keywords and/or Specific Medical Conditions
- Medtronic Intrepid TMVR System G160020/S007
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Mitral Valve Insufficiency
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Sponsors
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