COMPASSION S3 Post-Approval Study

NCT04860765 · tracked via the Priya Life Science USA tracker

Sponsor

Edwards Lifesciences

Phase

Observational

Started

2021-04-13

Last updated

2026-02-03

Condition(s) studied

Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve DegenerationPulmonary Valve; Obstruction

Investigational drug(s) / intervention(s)

SAPIEN 3 THV

SAPIEN 3 THV: SAPIEN 3 THV in the pulmonic position

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Dysfunctional RVOT conduit or previously implanted surgical valve 2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg Exclusion Criteria: 1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis or other active infections

Primary outcome measure(s)

Device Success — 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

Trial sites (19)

Facility	City	Region
University of Alabama	Birmingham	Alabama
Cedars Sinai	Los Angeles	California
Children's Hospital of Colorado	Aurora	Colorado
Advocate Childrens Hospital	Oak Lawn	Illinois
Boston Children's Hospital	Boston	Massachusetts
Minneapolis Heart	Minneapolis	Minnesota
St. Louis Children's Hospital	St Louis	Missouri
Newark Beth Israel Medical Center	Newark	New Jersey
Mount Sinai	New York	New York
Columbia University Medical Center/NYPH	New York	New York
Duke University	Durham	North Carolina
Cincinatti Children's Hospital	Cincinnati	Ohio
Nationwide Children's Hospital	Columbus	Ohio
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
Dell Children's	Austin	Texas
Children's Health Dallas	Dallas	Texas
Primary Children's	Salt Lake City	Utah
University of Virginia	Charlottesville	Virginia

More Edwards Lifesciences trials in the USA

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System Active, not recruiting

TTVR STRONG Under Coverage With Evidence Development (CED) Study Recruiting

Autus Valve Pivotal Study Active, not recruiting

SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation Active, not recruiting

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent Active, not recruiting

Other trials for the same condition

Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction Active, not recruiting

ALTERRA Post-Approval Study Active, not recruiting

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04860765 on ClinicalTrials.gov ↗ ← All trials in the USA