COMPASSION S3 Post-Approval Study

Active, not recruiting

• Conditions: Pulmonary Valve; Obstruction; Pulmonary Valve Degeneration; Complex Congenital Heart Defect; Dysfunctional RVOT Conduit; Pulmonary Valve Insufficiency
• Interventions: Device: SAPIEN 3 THV

• Registration Number: NCT04860765
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2021-04-13
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2030-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TPVR	SAPIEN 3 THV	Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Primary Outcome Measures

Name	Time	Method
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 Locations

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

Primary Children's; 🇺🇸 Salt Lake City, Utah, United States

Dell Children's; 🇺🇸 Austin, Texas, United States

Children's Health Dallas; 🇺🇸 Dallas, Texas, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Minneapolis Heart; 🇺🇸 Minneapolis, Minnesota, United States

St. Louis Children's Hospital; 🇺🇸 Saint 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

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States