Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

NARecruitingINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2031

Conditions
Tricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease
Interventions
DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

DRUG

Optimal Medical Therapy

Optimal Medical Therapy alone in patients with tricuspid regurgitation

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Trial Locations (79)

10032

RECRUITING

Columbia University Irving Medical Center/NYPH, New York

10065

RECRUITING

Weill Cornell Medicine, New York

10075

RECRUITING

Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset, New York

10467

RECRUITING

Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital, The Bronx

11576

RECRUITING

St. Francis Hospital, Roslyn

14203

RECRUITING

State University of New York at Buffalo, Buffalo

14621

ACTIVE_NOT_RECRUITING

Rochester General Hospital, Rochester

17033

RECRUITING

Penn State Hershey, Hershey

17043

RECRUITING

Pinnacle Health Cardiovascular Institute/UPMC Pinnacle, Wormleysburg

19096

RECRUITING

Lankenau Heart Institute, Wynnewood

19104

RECRUITING

Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania, Philadelphia

21287

RECRUITING

Johns Hopkins, Baltimore

22908

RECRUITING

University of Virginia Health System, Charlottesville

23298

ACTIVE_NOT_RECRUITING

Virginia Commonwealth University, Richmond

24014

RECRUITING

Carilion Medical Center, Roanoke

27517

RECRUITING

University of North Carolina, Chapel Hill

29245

ACTIVE_NOT_RECRUITING

Medical University of South Carolina, Charleston

30308

RECRUITING

Emory University Hospital Midtown / Emory University - St. Joseph's Hospital, Atlanta

30309

ACTIVE_NOT_RECRUITING

Piedmont Healthcare, Inc., Atlanta

32308

RECRUITING

Tallahassee Research Institute, Tallahassee

32605

RECRUITING

The Cardiac and Vascular Institute Research Foundation, Gainesville

33140

RECRUITING

Mount Sinai Medical Center, Miami Beach

34102

RECRUITING

NCH Healthcare System, Naples

34239

RECRUITING

Sarasota Memorial Health Care System, Sarasota

37212

ACTIVE_NOT_RECRUITING

Vanderbilt University Medical Center, Nashville

37403

ACTIVE_NOT_RECRUITING

Erlanger Health System, Chattanooga

43210

RECRUITING

The Ohio State University, Columbus

45219

RECRUITING

The Christ Hospital, Cincinnati

45242

ACTIVE_NOT_RECRUITING

TriHealth-Bethesda North Hospital, Cincinnati

46290

RECRUITING

Ascension St. Vincent Heart Center Cardiovascular Research Institute, Indianapolis

48073

RECRUITING

William Beaumont Hospital - Royal Oak, Royal Oak

48109

RECRUITING

University of Michigan, Ann Arbor

48202

RECRUITING

Henry Ford Hospital, Detroit

48601

ACTIVE_NOT_RECRUITING

St. Mary's of Ascension Research, Saginaw

52242

ACTIVE_NOT_RECRUITING

University of Iowa Hospitals & Clinics, Iowa City

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

55109

ACTIVE_NOT_RECRUITING

Fairview Health Services, Maplewood

55905

RECRUITING

Mayo Clinic, Rochester

58104

ACTIVE_NOT_RECRUITING

Sanford Medical Center Fargo, Fargo

59802

ACTIVE_NOT_RECRUITING

Providence St. Patrick Hospital, Missoula

60611

RECRUITING

Northwestern University, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

64111

RECRUITING

Saint Luke's Hospital of Kansas City, Kansas City

70121

ACTIVE_NOT_RECRUITING

Ochsner Medical Center, New Orleans

73112

ACTIVE_NOT_RECRUITING

Integris Baptist Medical Center, Oklahoma City

73120

RECRUITING

Oklahoma Cardiovascular Research Group, Oklahoma City

74104

RECRUITING

Oklahoma Heart Institute at Hillcrest Medical Center, Tulsa

75093

RECRUITING

Baylor Scott & White - The Heart Hospital - Plano, Plano

77004

RECRUITING

HCA Houston Healthcare Medical Center, Houston

77030

RECRUITING

Baylor College of Medicine St. Luke's Medical Center, Houston

RECRUITING

The University of Texas Health Science Center at Houston, Houston

RECRUITING

UTHealth/Memorial Hermann Hospital, Houston

80218

RECRUITING

St. Joseph Hospital, Denver

80538

ACTIVE_NOT_RECRUITING

Medical Center of the Rockies, Loveland

84107

ACTIVE_NOT_RECRUITING

Intermountain Medical Center, Murray

84790

RECRUITING

St. George Regional Hospital, St. George

85006

ACTIVE_NOT_RECRUITING

Banner University Medical Center Phoenix, Phoenix

85712

ACTIVE_NOT_RECRUITING

Tucson Medical Center Healthcare, Tucson

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90095

RECRUITING

UCLA Medical Center, Los Angeles

92037

ACTIVE_NOT_RECRUITING

SCPMG - Kaiser San Diego, La Jolla

92868

RECRUITING

University of California, Irvine, Irvine

94118

ACTIVE_NOT_RECRUITING

Kaiser Permanente San Francisco, San Francisco

94143

RECRUITING

University of California, San Francisco, San Francisco

94305

ACTIVE_NOT_RECRUITING

Stanford University, Stanford

97239

RECRUITING

Oregon Health & Science University, Portland

98101

RECRUITING

Virginia Mason Medical Center, Seattle

98122

RECRUITING

Swedish Medical Center, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

03756

RECRUITING

Dartmouth-Hitchcock Medical Center, Lebanon

09103

RECRUITING

Cooper Health Systems, Camden

07962

RECRUITING

Morristown Medical Center, Morristown

08901

RECRUITING

Rutgers Robert Wood Johnson Medical School, New Brunswick

V6Z 1Y6

ACTIVE_NOT_RECRUITING

St. Paul's Hospital, Vancouver

L8L 2X2

ACTIVE_NOT_RECRUITING

Hamilton Health Services, Hamilton

K1Y 4Q7

ACTIVE_NOT_RECRUITING

University of Ottawa Heart Institute, Ottawa

M4N 3M5

ACTIVE_NOT_RECRUITING

Sunnybrook Health Sciences Centre, Toronto

M5B 1W8

ACTIVE_NOT_RECRUITING

St. Michael's Hospital, Toronto

G1V 4G5

ACTIVE_NOT_RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, Québec

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY