COMPASSION S3 Post-Approval Study

Running, not enrolling

Conditions studied: Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Pulmonary Valve; Obstruction

In brief

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.

Key facts

Study ID

NCT04860765

Run by

Edwards Lifesciences

People needed

150

Starts

2021-04-13

Expected to finish

2030-08-01

Last updated by the study team

2026-02-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dysfunctional RVOT conduit or previously implanted surgical valve
• RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

You may not qualify if…

• Inability to tolerate an anticoagulation/antiplatelet regimen
• Active bacterial endocarditis or other active infections

Where it is running

• 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

Full record on ClinicalTrials.gov

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