Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. (APOLLO)

Investigator: Neal Kleiman, MD

Study Coordinator: Tia McGaughy

Status: Enrolling

ClinicalTrials.gov Number: NCT03242642

Phone: 346.238.4576

Protocol Number: Pro00018251

Description

Brief Summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. 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 <30% need for emergent or urgent surgery hemodynamic instability
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