Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Trial ID or NCT#
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
- - 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
- - prior transcatheter mitral valve procedure with device currently implanted - anatomic contraindications - prohibitive mitral annular calcification - left ventricular ejection fraction <30% - need for emergent or urgent surgery - hemodynamic instability