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)
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
