CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 86 enrolled
Drug / intervention
Edwards Alterra Adaptive Prestent with SAPIEN 3 THVdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03130777
NCT03130777N/AActive
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Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

Edwards Lifesciences·interventional·Posted Apr 26, 2017·Updated Sep 25, 2025

In Brief

A clinical study evaluating Edwards Alterra Adaptive Prestent with SAPIEN 3 THV for Pulmonary Disease and 4 related conditions. Active but no longer recruiting, targeting 86 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
CountriesUnited States
Collaborators--

Timeline

N/AActive
2017201820192020202120222023202420252026202720282029203020312032
First PostedApr 26, 2017
Enrollment StartAug 22, 2017
Primary CompletionJul 14, 2022
Study CompletionJun 1, 2032
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.2 years ago

Interventions

Edwards Alterra Adaptive Prestent with SAPIEN 3 THVdevice

The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.