ALTERRA Post-Approval Study

NCT05378386 · tracked via the Priya Life Science USA tracker

Sponsor

Edwards Lifesciences

Phase

Observational

Started

2022-05-12

Last updated

2025-11-04

Condition(s) studied

Pulmonary Valve InsufficiencyComplex Congenital Heart DefectTetralogy of FallotPulmonary RegurgitationRVOT Anomaly

Investigational drug(s) / intervention(s)

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV).

Study 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

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Native or surgically-repaired RVOT with severe PR 2. Clinically indicated for pulmonary valve replacement 3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV Exclusion Criteria: 1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis or other active infections

Primary outcome measure(s)

Acute Device Success — 24 hours post-procedure
Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation

Trial sites (24)

Facility	City	Region
Children's of Alabama	Birmingham	Alabama
Arkansas Children's Hospital	Little Rock	Arkansas
Cedars Sinai Medical Center	Los Angeles	California
Rady Children's Hospital	San Diego	California
Stanford University	Stanford	California
Colorado Children's Hospital	Aurora	Colorado
UF Health Shands Hospital	Gainesville	Florida
St. Joseph's Children's Hospital	Tampa	Florida
Advocate Children's Hospital	Oak Lawn	Illinois
Boston Children's Hospital	Boston	Massachusetts
Washington University in St. Louis	St Louis	Missouri
Icahn School of Medicine at Mount Sinai	New York	New York
Columbia University	New York	New York
Duke University	Durham	North Carolina
Cincinnati Children's Hospital	Cincinnati	Ohio
Nationwide Children's Hospital	Columbus	Ohio
UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
Le Bonheur Children's Hospital	Memphis	Tennessee
Medical City Dallas	Dallas	Texas
Children's Memorial Hermann Hospital	Houston	Texas
Texas Children's Hospital	Houston	Texas
Primary Children's Hospital	Salt Lake City	Utah
Seattle Children's Hospital	Seattle	Washington
Schneider Children's Medical Center of Israel	Petah Tikva	Israel

More Edwards Lifesciences trials in the USA

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System Active, not recruiting

TTVR STRONG Under Coverage With Evidence Development (CED) Study Recruiting

Autus Valve Pivotal Study Active, not recruiting

COMPASSION S3 Post-Approval Study Active, not recruiting

SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation Active, not recruiting

Other trials for the same condition

VenusP-Valve Pivotal Study (PROTEUS STUDY) Recruiting

COMPASSION S3 Post-Approval Study Active, not recruiting

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent Active, not recruiting

Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction Active, not recruiting

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05378386 on ClinicalTrials.gov ↗ ← All trials in the USA