Clinical Trials

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

    Investigator: Neal Kleiman

    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