Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Running, not enrolling · Not applicable
Conditions studied: Mitral Valve Insufficiency
In brief
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
Key facts
- Study ID
- NCT02322840
- Run by
- Medtronic Cardiovascular
- People needed
- 128
- Starts
- 2015-04-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Abrazo Arizona Heart Hospital - EFS — Phoenix, Arizona, United States
- Cedars-Sinai Medical Center - PILOT — Los Angeles, California, United States
- Piedmont Atlanta Hospital - PILOT — Atlanta, Georgia, United States
- Northwestern Memorial Hospital - PILOT — Chicago, Illinois, United States
- University of Michigan Health System - University Hospital - PILOT — Ann Arbor, Michigan, United States
- Corewell Health - EFS — Grand Rapids, Michigan, United States
- Abbott Northwestern Hospital - EFS — Minneapolis, Minnesota, United States
- Abbott Northwestern Hospital - PILOT — Minneapolis, Minnesota, United States
- Barnes Jewish Hospital - PILOT — St Louis, Missouri, United States
- NYU Langone Medical Center - PILOT — New York, New York, United States
- The Mount Sinai Hospital (New York NY) - EFS — New York, New York, United States
- The Mount Sinai Hospital (New York NY) - PILOT — New York, New York, United States
- New York-Presbyterian Hospital Columbia University Medical Center - EFS — New York, New York, United States
- New York-Presbyterian Hospital Columbia University Medical Center - PILOT — New York, New York, United States
- Oregon Health & Science University Hospital - EFS — Portland, Oregon, United States
- UPMC Pinnacle Harrisburg Campus - EFS — Wormleysburg, Pennsylvania, United States
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT — Dallas, Texas, United States
- Houston Methodist Hospital - PILOT — Houston, Texas, United States
- University of Virginia Medical Center - EFS — Charlottesville, Virginia, United States
- Aurora Saint Luke's Medical Center - EFS — Milwaukee, Wisconsin, United States
- Aurora Saint Lukes Medical Center - PILOT — Milwaukee, Wisconsin, United States
- Monash Health - PILOT — Clayton, Victoria, Australia
- The Alfred Hospital - PILOT — Melbourne, Australia
- Royal Prince Alfred Hospital - PILOT — Sydney, Australia
- Rigshospitalet - PILOT — Copenhagen, Denmark
Full record on ClinicalTrials.gov
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