COMPASSION S3 Post-Approval Study
AI Description
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.
- Who can join
- child, adult, older adult
- Participants
- 150
- Expected completion
- 2030-08
- Funded by
- industry
Conditions studied
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency, Pulmonary Valve; Obstruction
What is being tested
- DEVICE: SAPIEN 3 THV
What it measures
- Device Success, Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation, Discharge, expected to be within 1-5 days post-procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Barnes-Jewish Hospital
Saint Louis, MO
Boston Children's Hospital
Boston, MA
Cedars-Sinai Medical Center
Los Angeles, CA
Children's Hospital of Philadelphia
Philadelphia, PA
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
Dell Children's Medical Center
Austin, TX
Duke University Hospital
Durham, NC
Nationwide Children's Hospital
Columbus, OH
Newark Beth Israel Medical Center
Newark, NJ
The Mount Sinai Hospital
New York, NY
UAB Hospital
Birmingham, AL
University Medical Center
Charlottesville, VA
University of Colorado Hospital
Aurora, CO
University of Utah Health
Salt Lake City, UT
UPMC Presbyterian Shadyside
Pittsburgh, PA
William P. Clements Jr. University Hospital
Dallas, TX
Registry entry updated 2026-02-03
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.