Active — Not RecruitingNot Applicable

COMPASSION S3 Post-Approval Study

United States150 participantsStarted 2021-04-13

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Device Success

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

Trial details

NCT IDNCT04860765

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-08

View on ClinicalTrials.gov More Complex Congenital Heart Defect trials