COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

NARecruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

July 5, 2016

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2031

Conditions
Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve Degeneration
Interventions
DEVICE

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position

DEVICE

SAPIEN 3 THV

SAPIEN 3 THV in the pulmonic position

DEVICE

SAPIEN 3 Ultra RESILIA THV

SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Trial Locations (25)

10032

RECRUITING

Columbia University Medical Center/NYPH, New York

15224

RECRUITING

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

COMPLETED

Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia, Philadelphia

22908

RECRUITING

University of Virginia (UVA), Charlottesville

27710

RECRUITING

Duke University Medical Center, Durham

30322

RECRUITING

Emory University/Children's Healthcare of Atlanta, Atlanta

38103

RECRUITING

LeBonheur Children's Hopsital, Memphis

40536

WITHDRAWN

University of Kentucky, Lexington

43205

RECRUITING

Nationwide Children's Hospital, Columbus

45219

COMPLETED

The Lindner Research Center at Christ Hospital, Cincinnati

45229

RECRUITING

Cincinnati Children's Hospital, Cincinnati

55905

RECRUITING

Mayo Clinic Rochester, Rochester

63110

RECRUITING

St. Louis Children's Hospital, St Louis

COMPLETED

Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital, St Louis

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

75230

RECRUITING

Medical City Dallas, Dallas

75235

RECRUITING

Children's Health System of Texas / UT Southwestern Medical Center, Dallas

78229

RECRUITING

Methodist San Antonio, San Antonio

80045

RECRUITING

Childrens Hospital of Colorado, Aurora

84107

RECRUITING

Intermountain Heart Institute (IMC), Murray

90095

COMPLETED

University of California, Los Angeles, Los Angeles

94143

RECRUITING

University of California,, San Francisco (UCSF), San Francisco

98195

COMPLETED

University of Washington/Seattle Children's Hospital, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Boston Children's Hospital, Boston

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY