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COMPASSION S3 Post-Approval Study
Sponsor: Edwards Lifesciences
Summary
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
Official title: Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2021-04-13
Completion Date
2030-08
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
Locations (19)
University of Alabama
Birmingham, Alabama, United States
Cedars Sinai
Los Angeles, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Advocate Childrens Hospital
Oak Lawn, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Minneapolis Heart
Minneapolis, Minnesota, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mount Sinai
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinatti Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dell Children's
Austin, Texas, United States
Children's Health Dallas
Dallas, Texas, United States
Primary Children's
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States