Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Recruiting now · Not applicable
Conditions studied: Mitral Valve Regurgitation
In brief
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Key facts
- Study ID
- NCT03242642
- Run by
- Medtronic Cardiovascular
- People needed
- 1056
- Starts
- 2017-10-23
- Expected to finish
- 2036-09-30
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Abrazo Heart Hospital — Phoenix, Arizona, United States (enrolling)
- Scripps Memorial Hospital — La Jolla, California, United States (enrolling)
- PIH Health Good Samaritan Hospital — Los Angeles, California, United States (enrolling)
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
- Keck Hospital of the University of Southern California, USC — Los Angeles, California, United States (enrolling)
- Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
- El Camino Hospital — Mountain View, California, United States (enrolling)
- Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States (enrolling)
- Stanford Hospital and Clinics — Stanford, California, United States (enrolling)
- Los Robles Regional Medical Center — Thousand Oaks, California, United States (enrolling)
- Hartford Hospital — Hartford, Connecticut, United States (enrolling)
- Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
- JFK Medical Center — Atlantis, Florida, United States (enrolling)
- Morton Plant — Clearwater, Florida, United States (enrolling)
- HealthPark Medical Center — Fort Myers, Florida, United States (enrolling)
- North Florida Regional Medical Center — Gainesville, Florida, United States (enrolling)
- Baptist Medical Center Jacksonville — Jacksonville, Florida, United States (enrolling)
- University of South Florida Health — Tampa, Florida, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Piedmont Atlanta Hospital — Atlanta, Georgia, United States (enrolling)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- MercyOne Des Moines Medical Center — Des Moines, Iowa, United States (enrolling)
- University of Alabama Birmingham (UAB) Hospital — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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