Phase
Condition
Vascular Diseases
Mitral Valve Regurgitation
Treatment
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Moderate to severe or severe symptomatic mitral regurgitation
Local site multidisciplinary heart team experienced in mitral valve therapies agreesthat the subject is unsuitable for treatment with approved transcatheter repair orconventional mitral valve intervention
Exclusion
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
Connect with a study center
Royal Columbian Hospital
New Westminster, British Columbia V3L 3W7
CanadaActive - Recruiting
Saint Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
CanadaActive - Recruiting
St. Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Royal Columbian Hospital
New Westminster 6087844, British Columbia 5909050 V3L 3W7
CanadaSite Not Available
Saint Paul's Hospital
Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
CanadaSite Not Available
St. Paul's Hospital
Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
CanadaActive - Recruiting
Saint Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
Saint Michael's Hospital
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaSite Not Available
St. Michael's Hospital
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto 6167865, Ontario 6093943 M4N 3M5
CanadaActive - Recruiting
Glen Royal Victoria
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Glen Royal Victoria Hospital
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Montreal Heart Insitute
Montreal, Quebec H1T 1C8
CanadaActive - Recruiting
Glen Royal Victoria Hospital
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaActive - Recruiting
Montreal Heart Insitute
Montreal 6077243, Quebec 6115047 H1T 1C8
CanadaSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
Rigshospitalet
Copenhagen 2618425, 2100
DenmarkSite Not Available
University of Alabama Birmingham (UAB)
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama Birmingham (UAB) Hospital
Birmingham, Alabama 35233
United StatesActive - Recruiting
University of Alabama Birmingham (UAB)
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
University of Alabama Birmingham (UAB) Hospital
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Abrazo Heart Hospital
Phoenix, Arizona 85018
United StatesActive - Recruiting
Abrazo Heart Hospital
Phoenix 5308655, Arizona 5551752 85018
United StatesSite Not Available
Scripps Memorial Hospital
La Jolla, California 92037
United StatesActive - Recruiting
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United StatesActive - Recruiting
Keck Hospital of the University of Southern California
Los Angeles, California 90033
United StatesActive - Recruiting
Keck Hospital of the University of Southern California, USC
Los Angeles, California 90033
United StatesActive - Recruiting
PIH Health Good Samaritan Hospital
Los Angeles, California 90017
United StatesActive - Recruiting
El Camino
Mountain View, California 94040
United StatesSite Not Available
El Camino Hospital
Mountain View, California 94040
United StatesActive - Recruiting
Kaiser Permanente San Francisco Medical Center
San Francisco, California 94118-3100
United StatesActive - Recruiting
Stanford Hospital and Clinics
Stanford, California 94305
United StatesActive - Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California 91360-1847
United StatesActive - Recruiting
Scripps Memorial Hospital
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
Keck Hospital of the University of Southern California
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Keck Hospital of the University of Southern California, USC
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
PIH Health Good Samaritan Hospital
Los Angeles 5368361, California 5332921 90017
United StatesActive - Recruiting
El Camino
Mountain View 5375480, California 5332921 94040
United StatesActive - Recruiting
El Camino Hospital
Mountain View 5375480, California 5332921 94040
United StatesSite Not Available
Kaiser Permanente San Francisco Medical Center
San Francisco 5391959, California 5332921 94118-3100
United StatesSite Not Available
Stanford Hospital and Clinics
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
Los Robles Regional Medical Center
Thousand Oaks 5402405, California 5332921 91360-1847
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut 06102
United StatesActive - Recruiting
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
United StatesSite Not Available
Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
JFK Medical Center
Atlantis, Florida 33462
United StatesActive - Recruiting
Morton Plant
Clearwater, Florida 33756
United StatesActive - Recruiting
HealthPark Medical Center
Fort Myers, Florida 33908
United StatesActive - Recruiting
North Florida Regional Medical Center
Gainesville, Florida 32605
United StatesActive - Recruiting
Baptist Medical Center Jacksonville
Jacksonville, Florida 32207
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
University of South Florida Health
Tampa, Florida 33606
United StatesActive - Recruiting
JFK Medical Center
Atlantis 4146372, Florida 4155751 33462
United StatesSite Not Available
Morton Plant
Clearwater 4151316, Florida 4155751 33756
United StatesSite Not Available
HealthPark Medical Center
Fort Myers 4155995, Florida 4155751 33908
United StatesSite Not Available
North Florida Regional Medical Center
Gainesville 4156404, Florida 4155751 32605
United StatesSite Not Available
Baptist Medical Center Jacksonville
Jacksonville 4160021, Florida 4155751 32207
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33606
United StatesSite Not Available
Emory University
Atlanta, Georgia 30308
United StatesActive - Recruiting
Piedmont Atlanta Hospital
Atlanta, Georgia 30309
United StatesActive - Recruiting
Emory University
Atlanta 4180439, Georgia 4197000 30308
United StatesSite Not Available
Piedmont Atlanta Hospital
Atlanta 4180439, Georgia 4197000 30309
United StatesActive - Recruiting
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
United StatesActive - Recruiting
Mercy Medical Center
Des Moines, Iowa 50314
United StatesSite Not Available
MercyOne Des Moines Medical Center
Des Moines, Iowa 50314
United StatesActive - Recruiting
Mercy Medical Center
Des Moines 4853828, Iowa 4862182 50314
United StatesActive - Recruiting
MercyOne Des Moines Medical Center
Des Moines 4853828, Iowa 4862182 50314
United StatesSite Not Available
The University of Kansas Hospital
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
The University of Kansas Hospital
Kansas City 4273837, Kansas 4273857 66160
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
The Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesCompleted
The Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
University of Maryland Medical Center
Baltimore 4347778, Maryland 4361885 21201
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
University of Michigan Health System
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Ascension St. John Hospital
Detroit, Michigan 48236
United StatesActive - Recruiting
Henry Ford Saint John Hospital
Detroit, Michigan 48236
United StatesActive - Recruiting
Corewell Health
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Spectrum Health Hospital
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
University of Michigan Health System
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Henry Ford Saint John Hospital
Detroit 4990729, Michigan 5001836 48236
United StatesSite Not Available
Corewell Health
Grand Rapids 4994358, Michigan 5001836 49503
United StatesSite Not Available
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Abbott Northwestern Hospital
Minneapolis 5037649, Minnesota 5037779 55407
United StatesActive - Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis 5037649, Minnesota 5037779 55455
United StatesSite Not Available
Barnes-Jewish Hospital
Saint Louis, Missouri 63110-1003
United StatesSite Not Available
Barnes-Jewish Hospital
St Louis, Missouri 63110-1003
United StatesActive - Recruiting
Barnes-Jewish Hospital
St Louis 4407066, Missouri 4398678 63110-1003
United StatesSite Not Available
Providence St Patrick
Missoula, Montana 59802-4008
United StatesActive - Recruiting
Providence St Patrick
Missoula 5666639, Montana 5667009 59802-4008
United StatesSite Not Available
AHS (Atlantic Health System)
Morristown, New Jersey 07960
United StatesActive - Recruiting
Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Morristown Memorial Hospital
Morristown, New Jersey 07960
United StatesActive - Recruiting
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune City, New Jersey 07753
United StatesActive - Recruiting
Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753
United StatesSite Not Available
North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Northwell Health North Shore University Hospital
Manhasset, New York 11030
United StatesActive - Recruiting
NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesSite Not Available
Columbia University Medical Center/NYPH
New York, New York 10032
United StatesActive - Recruiting
Montefiore Medical Center
New York, New York 10467-2401
United StatesActive - Recruiting
NYU Langone Medical Center
New York, New York 10016
United StatesActive - Recruiting
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
The Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Saint Francis Hospital
Roslyn, New York 11576
United StatesActive - Recruiting
North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
United StatesActive - Recruiting
Northwell Health North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
United StatesSite Not Available
NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
United StatesSite Not Available
Montefiore Medical Center
New York 5128581, New York 5128638 10467-2401
United StatesActive - Recruiting
NYU Langone Medical Center
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
New York-Presbyterian Hospital Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
The Mount Sinai Hospital
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Saint Francis Hospital
Roslyn 5134415, New York 5128638 11576
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
The Christ Hospital
Cincinnati, Ohio 45219-2906
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
OhioHealth Riverside Methodist Hospital
Columbus, Ohio 43214
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219-2906
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
OhioHealth Riverside Methodist Hospital
Columbus 4509177, Ohio 5165418 43214
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
INTEGRIS Baptist Medical Center
Oklahoma City 4544349, Oklahoma 4544379 73112
United StatesSite Not Available
Oregon Health & Science University Hospital
Portland, Oregon 97239
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United StatesActive - Recruiting
Oregon Health & Science University Hospital
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Providence Saint Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
United StatesActive - Recruiting
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania 17101
United StatesActive - Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United StatesActive - Recruiting
UPMC Pinnacle Harrisburg Campus
Harrisburg 5192726, Pennsylvania 6254927 17101
United StatesSite Not Available
UPMC Presbyterian
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Lankenau Medical Center
Wynnewood 5220230, Pennsylvania 6254927 19096
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37203
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Heart Hospital of Austin
Austin, Texas 78756
United StatesActive - Recruiting
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas 75246
United StatesSite Not Available
Texas Health Presbyterian Hospital Dallas
Dallas, Texas 75231
United StatesActive - Recruiting
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
Baylor Scott & White Health (The Heart Hospital Baylor Plano)
Plano, Texas 75093
United StatesSite Not Available
The Heart Hospital Baylor Plano
Plano, Texas 75093
United StatesActive - Recruiting
Methodist Hospital
San Antonio, Texas 78229
United StatesActive - Recruiting
Heart Hospital of Austin
Austin 4671654, Texas 4736286 78756
United StatesSite Not Available
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Texas Health Presbyterian Hospital Dallas
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Baylor Scott & White Health (The Heart Hospital Baylor Plano)
Plano 4719457, Texas 4736286 75093
United StatesActive - Recruiting
The Heart Hospital Baylor Plano
Plano 4719457, Texas 4736286 75093
United StatesSite Not Available
Methodist Hospital
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
The University of Vermont Medical Center
Burlington, Vermont 05401-1473
United StatesActive - Recruiting
The University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401-1473
United StatesSite Not Available
University of Virginia Medical Center
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Inova Fairfax Hospital
Fairfax, Virginia 22042
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507-1904
United StatesActive - Recruiting
Saint Mary's Hospital/Bon Secours
Richmond, Virginia 23226
United StatesSite Not Available
Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24014
United StatesActive - Recruiting
Winchester Medical Center
Winchester, Virginia 22601
United StatesSite Not Available
University of Virginia Medical Center
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available
Inova Fairfax Hospital
Fairfax 4758023, Virginia 6254928 22042
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507-1904
United StatesSite Not Available
Saint Mary's Hospital/Bon Secours
Richmond 4781708, Virginia 6254928 23226
United StatesSite Not Available
Carilion Roanoke Memorial Hospital
Roanoke 4782167, Virginia 6254928 24014
United StatesSite Not Available
Winchester Medical Center
Winchester 4794120, Virginia 6254928 22601
United StatesSite Not Available
The Swedish Medical Center Cherry Hill
Seattle, Washington 98122
United StatesSite Not Available
University of Washington
Seattle, Washington 98195
United StatesSite Not Available
University of Washington (UW) Medical Center
Seattle, Washington 98195
United StatesActive - Recruiting
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington 99204
United StatesActive - Recruiting
The Swedish Medical Center Cherry Hill
Seattle 5809844, Washington 5815135 98122
United StatesSite Not Available
University of Washington
Seattle 5809844, Washington 5815135 98195
United StatesActive - Recruiting
University of Washington (UW) Medical Center
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available
Providence Sacred Heart Medical Center & Children's Hospital
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesActive - Recruiting
Aurora St. Luke's Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215
United StatesSite Not Available

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