Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Purpose
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Condition
- Mitral Valve Regurgitation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Primary Cohort- TMVR |
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) |
|
|
Experimental Mitral Annular Calcification -TMVR |
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) |
|
Recruiting Locations
University of Alabama Birmingham (UAB) Hospital
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Abrazo Heart Hospital
Phoenix, Arizona 85018
Phoenix, Arizona 85018
Scripps Memorial Hospital
La Jolla, California 92037
La Jolla, California 92037
PIH Health Good Samaritan Hospital
Los Angeles, California 90017
Los Angeles, California 90017
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Keck Hospital of the University of Southern California, USC
Los Angeles, California 90033
Los Angeles, California 90033
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
El Camino Hospital
Mountain View, California 94040
Mountain View, California 94040
Kaiser Permanente San Francisco Medical Center
San Francisco, California 94118-3100
San Francisco, California 94118-3100
Stanford Hospital and Clinics
Stanford, California 94305
Stanford, California 94305
Los Robles Regional Medical Center
Thousand Oaks, California 91360-1847
Thousand Oaks, California 91360-1847
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Yale New Haven Hospital
New Haven, Connecticut 06510
New Haven, Connecticut 06510
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
JFK Medical Center
Atlantis, Florida 33462
Atlantis, Florida 33462
HealthPark Medical Center
Fort Myers, Florida 33908
Fort Myers, Florida 33908
North Florida Regional Medical Center
Gainesville, Florida 32605
Gainesville, Florida 32605
Baptist Medical Center Jacksonville
Jacksonville, Florida 32207
Jacksonville, Florida 32207
University of South Florida Health
Tampa, Florida 33606
Tampa, Florida 33606
Emory University
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Piedmont Atlanta Hospital
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Northwestern Memorial Hospital
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
MercyOne Des Moines Medical Center
Des Moines, Iowa 50314
Des Moines, Iowa 50314
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
The Johns Hopkins Hospital
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Michigan Health System
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Henry Ford Saint John Hospital
Detroit, Michigan 48236
Detroit, Michigan 48236
Corewell Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Barnes-Jewish Hospital
St Louis, Missouri 63110-1003
St Louis, Missouri 63110-1003
Providence St Patrick
Missoula, Montana 59802-4008
Missoula, Montana 59802-4008
Morristown Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Jersey Shore University Medical Center
Neptune City, New Jersey 07753
Neptune City, New Jersey 07753
Northwell Health North Shore University Hospital
Manhasset, New York 11030
Manhasset, New York 11030
NYU Langone Hospital - Long Island
Mineola, New York 11501
Mineola, New York 11501
NYU Langone Medical Center
New York, New York 10016
New York, New York 10016
The Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Montefiore Medical Center
New York, New York 10467-2401
New York, New York 10467-2401
Saint Francis Hospital
Roslyn, New York 11576
Roslyn, New York 11576
The Christ Hospital
Cincinnati, Ohio 45219-2906
Cincinnati, Ohio 45219-2906
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
OhioHealth Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Oregon Health & Science University Hospital
Portland, Oregon 97239
Portland, Oregon 97239
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania 17101
Harrisburg, Pennsylvania 17101
UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Vanderbilt University Medical Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Heart Hospital of Austin
Austin, Texas 78756
Austin, Texas 78756
Texas Health Presbyterian Hospital Dallas
Dallas, Texas 75231
Dallas, Texas 75231
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Houston, Texas 77030
Houston, Texas 77030
Houston Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Methodist Hospital
San Antonio, Texas 78229
San Antonio, Texas 78229
The University of Vermont Medical Center
Burlington, Vermont 05401-1473
Burlington, Vermont 05401-1473
University of Virginia Medical Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Inova Fairfax Hospital
Fairfax, Virginia 22042
Fairfax, Virginia 22042
Sentara Norfolk General Hospital
Norfolk, Virginia 23507-1904
Norfolk, Virginia 23507-1904
Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24014
Roanoke, Virginia 24014
University of Washington (UW) Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington 99204
Spokane, Washington 99204
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
More Details
- NCT ID
- NCT03242642
- Status
- Recruiting
- Sponsor
- Medtronic Cardiovascular