Clinical Trial

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Active, Not Recruiting
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Summary
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2017-04-24; most recent amendment 2025-09-23.
Status change: Recruiting → Active, Not Recruiting 2021-11-23
Status change: Active, Not Recruiting → Recruiting 2021-06-30
Status change: Recruiting → Active, Not Recruiting 2021-04-15
Status change: Not Yet Recruiting → Recruiting 2017-08-25
Trial Details
NCT Number NCT03130777
Lead Sponsor Edwards Lifesciences
Conditions Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
Enrollment 86 participants
Start Date 2017-08-22
Primary Completion 2022-07-14 (estimated)
Study Completion 2032-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-25