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NCT03242642NARecruiting

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Medtronic Cardiovascular

Start Date

10/23/2017

Completion Date

9/30/2036

Summary

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

DEVICE

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

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Conditions

Mitral Valve Regurgitation

Locations

University of Alabama Birmingham (UAB) Hospital

Birmingham, Alabama 35233

United States

Abrazo Heart Hospital

Phoenix, Arizona 85018

United States

Scripps Memorial Hospital

La Jolla, California 92037

United States

PIH Health Good Samaritan Hospital

Los Angeles, California 90017

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California 90027

United States

Keck Hospital of the University of Southern California, USC

Los Angeles, California 90033

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

El Camino Hospital

Mountain View, California 94040

United States

Kaiser Permanente San Francisco Medical Center

San Francisco, California 94118-3100

United States

Stanford Hospital and Clinics

Stanford, California 94305

United States

Los Robles Regional Medical Center

Thousand Oaks, California 91360-1847

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Yale New Haven Hospital

New Haven, Connecticut 06510

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

JFK Medical Center

Atlantis, Florida 33462

United States

Morton Plant

Clearwater, Florida 33756

United States

HealthPark Medical Center

Fort Myers, Florida 33908

United States

North Florida Regional Medical Center

Gainesville, Florida 32605

United States

Baptist Medical Center Jacksonville

Jacksonville, Florida 32207

United States

University of South Florida Health

Tampa, Florida 33606

United States

Emory University

Atlanta, Georgia 30308

United States

Piedmont Atlanta Hospital

Atlanta, Georgia 30309

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

MercyOne Des Moines Medical Center

Des Moines, Iowa 50314

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

University of Maryland Medical Center

Baltimore, Maryland 21201

United States

The Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

Henry Ford Saint John Hospital

Detroit, Michigan 48236

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota 55455

United States

Barnes-Jewish Hospital

St Louis, Missouri 63110-1003

United States

Providence St Patrick

Missoula, Montana 59802-4008

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Jersey Shore University Medical Center

Neptune City, New Jersey 07753

United States

Northwell Health North Shore University Hospital

Manhasset, New York 11030

United States

NYU Langone Hospital - Long Island

Mineola, New York 11501

United States

NYU Langone Medical Center

New York, New York 10016

United States

The Mount Sinai Hospital

New York, New York 10029

United States

New York-Presbyterian Hospital Columbia University Medical Center

New York, New York 10032

United States

Montefiore Medical Center

New York, New York 10467-2401

United States

Saint Francis Hospital

Roslyn, New York 11576

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

The Christ Hospital

Cincinnati, Ohio 45219-2906

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma 73112

United States

Providence Saint Vincent Medical Center

Portland, Oregon 97225

United States

Oregon Health & Science University Hospital

Portland, Oregon 97239

United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania 17101

United States

UPMC Presbyterian

Pittsburgh, Pennsylvania 15213

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37203

United States

Heart Hospital of Austin

Austin, Texas 78756

United States

Texas Health Presbyterian Hospital Dallas

Dallas, Texas 75231

United States

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas 75246

United States

CHI Saint Luke's Health-Baylor Saint Luke's Medical Center

Houston, Texas 77030

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

The Heart Hospital Baylor Plano

Plano, Texas 75093

United States

Methodist Hospital

San Antonio, Texas 78229

United States

The University of Vermont Medical Center

Burlington, Vermont 05401-1473

United States

University of Virginia Medical Center

Charlottesville, Virginia 22908

United States

Inova Fairfax Hospital

Fairfax, Virginia 22042

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507-1904

United States

Saint Mary's Hospital/Bon Secours

Richmond, Virginia 23226

United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia 24014

United States

Winchester Medical Center

Winchester, Virginia 22601

United States

The Swedish Medical Center Cherry Hill

Seattle, Washington 98122

United States

University of Washington (UW) Medical Center

Seattle, Washington 98195

United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington 99204

United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 53215

United States

Royal Columbian Hospital

New Westminster, British Columbia V3L 3W7

Canada

Saint Paul's Hospital

Vancouver, British Columbia V6Z 1Y6

Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

Saint Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Montreal Heart Insitute

Montreal, Quebec H1T 1C8

Canada

Glen Royal Victoria Hospital

Montreal, Quebec H4A 3J1

Canada

Rigshospitalet

Copenhagen, 2100

Denmark