Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Medtronic Cardiovascular
Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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
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)
- University of Alabama Birmingham (UAB) HospitalBirmingham, Alabama
- Abrazo Heart HospitalPhoenix, Arizona
- Scripps Memorial HospitalLa Jolla, California
- PIH Health Good Samaritan HospitalLos Angeles, California
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
- Keck Hospital of the University of Southern California, USCLos Angeles, California