Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Trial ID or NCT#
NCT03242642
Status
RECRUITING
Purpose
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Official Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts 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 <30% - need for emergent or urgent surgery - hemodynamic instability
Investigator(s)
William Fearon, MD
Interventional cardiologist,
Cardiologist
Professor of Medicine (Cardiovascular Medicine)
David Lee, MD
Cardiologist,
Interventional cardiologist
Professor of Medicine (Cardiovascular Medicine)
Rahul P Sharma, MBBS, FRACP
Cardiologist,
Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Christiane Haeffele
Cardiologist,
Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Clinical Assistant Professor, Pediatrics - Cardiology
Jack Boyd
Cardiac surgeon,
Cardiothoracic surgeon,
Heart transplant surgeon,
Heart and lung transplant surgeon,
Vascular surgeon,
Cardiovascular surgeon,
Lung transplant surgeon
Clinical Associate Professor, Cardiothoracic Surgery
View on ClinicalTrials.gov