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

• 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

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

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

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