Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
- Conditions
- Mitral Valve Regurgitation
- Interventions
- Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
- Registration Number
- NCT03242642
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1056
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Primary Cohort- TMVR Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) Mitral Annular Calcification -TMVR Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
- Primary Outcome Measures
Name Time Method Primary Cohort 1 year The rate of all-cause mortality or heart failure hospitalization
MAC Cohort 1 year all-cause mortality
- Secondary Outcome Measures
Name Time Method Cardiovascular hospitalizations 1 year cardiovascular hospitalizations
all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding 30 days or hospital discharge (whichever is later) Composite
Change in New York Heart Association Class 30 days change in NYHA Class
Quality of Life Improvement 30 days (SF-12) and 3 months (KCCQ) measured by SF-12 and KCCQ
Echocardiographic assessments of degree mitral valve regurgitation 1 year measured by echocardiography
Trial Locations
- Locations (85)
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Providence Saint Vincent Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
UPMC Pinnacle Harrisburg Campus
🇺🇸Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Texas Health Presbyterian Hospital Dallas
🇺🇸Dallas, Texas, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
🇺🇸Houston, Texas, United States
Inova Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Baylor Scott & White Health (The Heart Hospital Baylor Plano)
🇺🇸Plano, Texas, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Saint Mary's Hospital/Bon Secours
🇺🇸Richmond, Virginia, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
The Swedish Medical Center Cherry Hill
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Providence Sacred Heart Medical Center & Children's Hospital
🇺🇸Spokane, Washington, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Montreal Heart Insitute
🇨🇦Montreal, Quebec, Canada
Glen Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Rigshospitalet
🇩🇰Copenhagen, Denmark
Abrazo Heart Hospital
🇺🇸Phoenix, Arizona, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
El Camino
🇺🇸Mountain View, California, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
HealthPark Medical Center
🇺🇸Fort Myers, Florida, United States
University of Alabama Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
New York-Presbyterian Hospital Columbia University Medical Center
🇺🇸New York, New York, United States
Keck Hospital of the University of Southern California
🇺🇸Los Angeles, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Morton Plant
🇺🇸Clearwater, Florida, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
PIH Health Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente San Francisco Medical Center
🇺🇸San Francisco, California, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Baptist Medical Center Jacksonville
🇺🇸Jacksonville, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Saint John Hospital
🇺🇸Detroit, Michigan, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center - East Bank
🇺🇸Minneapolis, Minnesota, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Mercy Medical Center
🇺🇸Des Moines, Iowa, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
The University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Providence St Patrick
🇺🇸Missoula, Montana, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Montefiore Medical Center
🇺🇸New York, New York, United States