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 \<25%* 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)
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
Christiane Haeffele
Cardiologist,
Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Clinical Assistant Professor, Pediatrics - Cardiology
Rahul P Sharma, MBBS, FRACP
Cardiologist,
Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
View on ClinicalTrials.gov
