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Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Recruiting
Trial ID: NCT03242642
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
Stanford Investigator(s)
William Fearon, MD
Professor of Medicine (Cardiovascular Medicine)
David Lee, MD
Professor of Medicine (Cardiovascular Medicine)
Rahul P Sharma, MBBS, FRACP
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Jack Boyd
Clinical Associate Professor, Cardiothoracic Surgery
Christiane Haeffele
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Eligibility
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
Intervention(s):
device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305