RecruitingNot ApplicableNCT03242642
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Sponsor
Medtronic Cardiovascular
Enrollment
1,056 participants
Start Date
Oct 23, 2017
Study Type
INTERVENTIONAL
Conditions
Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Moderate to severe or severe symptomatic mitral regurgitation
- Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Exclusion Criteria6
- 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
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Interventions
DEVICEMedtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
mitral valve replacement
DEVICEMedtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Locations(85)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03242642
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