Clinical Trial

ALTERRA Post-Approval Study

Active, Not Recruiting
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Summary
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-05-12; most recent amendment 2025-10-31.
Status change: Recruiting → Active, Not Recruiting 2025-10-31
Status change: Not Yet Recruiting → Recruiting 2022-06-13
Trial Details
NCT Number NCT05378386
Lead Sponsor Edwards Lifesciences
Conditions Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly
Enrollment 150 participants
Start Date 2022-05-12
Primary Completion 2025-09-25 (estimated)
Study Completion 2035-07 (estimated)
Updated on ClinicalTrials.gov 2025-11-04