ALTERRA Post-Approval Study

NCT05378386 | Active Not Recruiting

• 1 other identifier: 2021-11
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 24

Brief 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

Conditions

Pulmonary Valve Insufficiency; Complex Congenital Heart Defect; Tetralogy of Fallot; Pulmonary Regurgitation; RVOT Anomaly

Keywords

Alterra prestent; SAPIEN 3; Pulmonic Delivery System; Transcatheter pulmonary valve replacement; Transcatheter pulmonary valve implantation

Outcome Measures

Primary Outcomes (1)

• Acute Device Success

  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

  24 hours post-procedure

Study Arms (1)

TPVR

Transcatheter Pulmonary Valve Replacement

Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Interventions

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System DEVICE

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).

TPVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with severe PR who have a native or surgically-repaired RVOT, are clinically indicated for pulmonary valve replacement, and are planned for treatment with the Alterra prestent and SAPIEN 3 THV

You may qualify if:

• Native or surgically-repaired RVOT with severe PR
• Clinically indicated for pulmonary valve replacement
• Planned for treatment with the Alterra prestent and SAPIEN 3 THV

You may not qualify if:

• Inability to tolerate an anticoagulation/antiplatelet regimen
• Active bacterial endocarditis or other active infections

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (24)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Colorado Children's Hospital

Aurora, Colorado, 80045, United States

Location

UF Health Shands Hospital

Gainesville, Florida, 32669, United States

Location

St. Joseph's Children's Hospital

Tampa, Florida, 33607, United States

Location

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Pulmonary Valve Insufficiency; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: May 12, 2022
• Primary Completion: September 25, 2025
• Study Completion (Estimated): July 1, 2035
• Last Updated: November 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (23)