COMPASSION S3 Post-Approval Study

Active, not recruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

April 13, 2021

Primary Completion Date

August 31, 2030

Study Completion Date

August 31, 2030

Conditions
Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve DegenerationPulmonary Valve; Obstruction
Interventions
DEVICE

SAPIEN 3 THV

SAPIEN 3 THV in the pulmonic position

Trial Locations (19)

10029

Mount Sinai, New York

10032

Columbia University Medical Center/NYPH, New York

19104

Children's Hospital of Philadelphia, Philadelphia

19146

University of Pittsburgh Medical Center, Pittsburgh

22908

University of Virginia, Charlottesville

27710

Duke University, Durham

35487

University of Alabama, Birmingham

43215

Nationwide Children's Hospital, Columbus

45229

Cincinatti Children's Hospital, Cincinnati

55407

Minneapolis Heart, Minneapolis

60453

Advocate Childrens Hospital, Oak Lawn

63110

St. Louis Children's Hospital, St Louis

75235

Children's Health Dallas, Dallas

78723

Dell Children's, Austin

80045

Children's Hospital of Colorado, Aurora

84108

Primary Children's, Salt Lake City

90048

Cedars Sinai, Los Angeles

02115

Boston Children's Hospital, Boston

07112

Newark Beth Israel Medical Center, Newark

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY

NCT04860765 - COMPASSION S3 Post-Approval Study | Biotech Hunter | Biotech Hunter