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Clinical Trials in the USA / NCT05378386
Active, not recruiting Observational

ALTERRA Post-Approval Study

NCT05378386 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Observational
Started
2022-05-12
Last updated
2026-10-05

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
No
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)

FacilityCityRegionStatus
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

ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Active, not recruiting
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) Recruiting
PARTNER 3 Trial - Aortic Valve-in-Valve Recruiting
COMPASSION S3 Post-Approval Study Active, not recruiting
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System Active, not recruiting

Other trials for the same condition

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study Active, not recruiting
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction Active, not recruiting
COMPASSION S3 Post-Approval Study Active, not recruiting
VenusP-Valve Pivotal Study (PROTEUS STUDY) Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction 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