Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

NARecruitingINTERVENTIONAL
Enrollment

958

Participants

Timeline

Start Date

June 15, 2018

Primary Completion Date

May 15, 2024

Study Completion Date

June 30, 2028

Conditions
Mitral RegurgitationMitral InsufficiencyMitral Valve InsufficiencyCardiovascular DiseasesValve Disease, HeartHeart Valve DiseasesFunctional Mitral RegurgitationDegenerative Mitral Valve Disease
Interventions
DEVICE

Tendyne Mitral Valve System

Mitral valve replacement

DEVICE

MitraClip System

Percutaneous mitral valve repair using the MitraClip system.

Trial Locations (80)

10065

RECRUITING

New York Presbyterian Hospital/ Weill Cornell Medical Center, New York

10075

RECRUITING

Lenox Hill Hospital, New York

11706

RECRUITING

South Shore University Hospital, Bay Shore

12208

RECRUITING

Albany Medical College at Albany Medical Center, Albany

14203

RECRUITING

Buffalo General Hospital, Buffalo

15212

RECRUITING

Allegheny General Hospital - ASRI, Pittsburgh

15232

RECRUITING

UPMC Shadyside, Pittsburgh

20904

TERMINATED

Adventist HealthCare White Oak Medical Center, Silver Spring

21201

ACTIVE_NOT_RECRUITING

University of Maryland Medical Center, Baltimore

21218

RECRUITING

MedStar Health Research Institute, Balitmore

22042

TERMINATED

Inova Fairfax Hospital, Falls Church

22908

RECRUITING

University of Virginia Medical Center, Charlottesville

26506

RECRUITING

West Virginia University Hospital, Morgantown

28203

RECRUITING

Carolinas Medical Center, Charlotte

28204

RECRUITING

Novant Health Heart and Vascular Research Institute, Charlotte

28801

RECRUITING

Mission Health & Hospitals, Asheville

29425

RECRUITING

Medical University of South Carolina, Charleston

30060

RECRUITING

Wellstar Kennestone Hospital, Marietta

30309

RECRUITING

Piedmont Heart Institute, Atlanta

30322

RECRUITING

Emory University Hospital, Atlanta

32308

RECRUITING

Tallahassee Research Institute, Tallahassee

32605

TERMINATED

North Florida Regional Medical Center, Gainesville

32610

RECRUITING

Shands at the University of Florida, Gainesville

33176

TERMINATED

Baptist Hospital of Miami, Miami

33331

RECRUITING

Cleveland Clinic Florida, Weston

33484

TERMINATED

Delray Medical Center, Delray Beach

33756

RECRUITING

Morton Plant Hospital, Clearwater

34208

TERMINATED

Manatee Memorial Hospital, Bradenton

35211

TERMINATED

Princeton Baptist Medical Center, Birmingham

35233

RECRUITING

UAB University Hospital, Birmingham

37203

RECRUITING

Centennial Medical Center, Nashville

37205

RECRUITING

St. Thomas Hospital, Nashville

38120

RECRUITING

Baptist Memorial Hospital, Memphis

44195

RECRUITING

The Cleveland Clinic Foundation, Cleveland

45219

RECRUITING

University of Cincinnati Medical Center, Cincinnati

46260

RECRUITING

St. Vincent Hospital, Indianapolis

48073

WITHDRAWN

Beaumont Hospital, Royal Oak

48109

RECRUITING

University of Michigan, Ann Arbor

48202

RECRUITING

Henry Ford Hospital, Detroit

53226

TERMINATED

Medical College of Wisconsin, Milwaukee

55407

RECRUITING

Abbott Northwestern Hospital, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

59802

RECRUITING

The International Heart Institute of Montana, Missoula

60453

RECRUITING

Advocate Christ Medical Center, Oak Lawn

60612

TERMINATED

Rush University Medical Center, Chicago

62701

ACTIVE_NOT_RECRUITING

Prairie Education & Research Cooperative, Springfield

63110

ACTIVE_NOT_RECRUITING

St. Louis University Hospital, St Louis

64111

RECRUITING

St. Luke's Hospital, Kansas City

67226

RECRUITING

Cardiovascular Research Institute of Kansas, Wichita

72205

RECRUITING

Baptist Health Medical Center, Little Rock

74104

RECRUITING

Oklahoma Heart Institute at Utica, Tulsa

75226

ACTIVE_NOT_RECRUITING

Baylor Scott & White Heart and Vascular Hospital, Dallas

75230

TERMINATED

Medical City Dallas Hospital, Dallas

77030

RECRUITING

Memorial Hermann Hospital, Houston

78756

RECRUITING

Cardiothoracic & Vascular Surgeons, Austin

80045

TERMINATED

University of Colorado Hospital, Aurora

83706

TERMINATED

St. Alphonsus Regional Medical Center, Boise

85006

RECRUITING

Banner-University Medical Center, Phoenix

85258

RECRUITING

HonorHealth Scottsdale Shea Medical Center, Scottsdale

90033

TERMINATED

University of Southern California University Hospital, Los Angeles

90048

ACTIVE_NOT_RECRUITING

Cedars-Sinai Medical Center, Los Angeles

91360

RECRUITING

Los Robles Hospital and Medical Center, Thousand Oaks

92123

RECRUITING

San Diego Cardiac Center, San Diego

93720

TERMINATED

Fresno Heart Hospital, Fresno

94143

TERMINATED

University of California at San Francisco, San Francisco

94305

RECRUITING

Stanford Health Care, Stanford

95816

TERMINATED

Sutter Medical Center, Sacramento, Sacramento

95817

RECRUITING

University of California - Davis Medical Center, Sacramento

97225

RECRUITING

Providence Heart & Vascular Institute, Portland

98122

RECRUITING

Swedish Medical Center - Heart & Vascular, Seattle

02215

WITHDRAWN

Beth Israel Deaconess Medical Center, Boston

03102

TERMINATED

Catholic Medical Center, Manchester

07601

RECRUITING

Hackensack University Medical Center, Hackensack

08901

RECRUITING

Robert Wood Johnson University Hospital, New Brunswick

07112

RECRUITING

Newark Beth Israel Medical Center, Newark

K1Y 4W7

TERMINATED

Ottawa Heart Institute, Ottawa

M4N 3M5

ACTIVE_NOT_RECRUITING

Sunnybrook Health Sciences Centre, Toronto

M5B 1W8

ACTIVE_NOT_RECRUITING

St. Michael's Hospital, Toronto

H1T 1C8

ACTIVE_NOT_RECRUITING

Institut de Cardiologie de Montreal (Montreal Heart Institute), Montreal

H4A 3J1

ACTIVE_NOT_RECRUITING

The Royal Victoria Hospital, Montreal

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY