COMPASSION S3 Post-Approval Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Complex Congenital Heart Defect Bites and Stings Cardiovascular Diseases Chemically-Induced Disorders Dysfunctional RVOT Conduit Heart Diseases Heart Valve Diseases Poisoning Pulmonary Valve Degeneration Pulmonary Valve Insufficiency Pulmonary Valve; Obstruction Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

About this study

This is a single arm, prospective, multicenter post-approval study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SAPIEN 3 THV

Device

SAPIEN 3 THV in the pulmonic position

Primary outcomes

Device Success

Time frame: Discharge, expected to be within 1-5 days post-procedure
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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study

Important dates

Study start: 2021
Primary completion: 2030
Study completion: 2030
First posted: Apr 27, 2021
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting