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Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Sponsor: Medtronic Cardiovascular
Summary
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
Official title: An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2015-04
Completion Date
2028-12
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
Twelve TMVR Implant
Implantation of the Twelve TMVR System - Apical
Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral
Locations (32)
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
Helsinki University Hospital - PILOT
Helsinki, Finland
Centre Hospitalier Régional Universitaire de Lille - PILOT
Lille, France
Clinique Pasteur - PILOT
Toulouse, France
Hygeia Hospital - PILOT
Athens, Greece
Royal Sussex County Hospital - PILOT
Brighton, United Kingdom
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary - PILOT
Leeds, United Kingdom
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital - PILOT
London, United Kingdom