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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)
Christiane Haeffele
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Jack Boyd
Clinical Associate Professor, Cardiothoracic Surgery
Rahul P Sharma, MBBS, FRACP
Clinical Associate Professor, Medicine - Cardiovascular Medicine
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