ALTERRA Post-Approval Study

Recruiting

• Conditions: Tetralogy of Fallot; RVOT Anomaly; Complex Congenital Heart Defect; Pulmonary Regurgitation; Pulmonary Valve Insufficiency
• Interventions: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

• Registration Number: NCT05378386
• Lead Sponsor: Edwards Lifesciences

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

Detailed Description

This is a single arm, prospective, multicenter post-approval study.

Study Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-07
• Study Completion: 2035-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TPVR	Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System	Transcatheter Pulmonary Valve Replacement

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (22)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

UPMC Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Stanford University; 🇺🇸 Stanford, California, United States

Rady's Children's Hospital; 🇺🇸 San Diego, California, United States

Advocate Children's Hospital; 🇺🇸 Oak Lawn, Illinois, United States

Colorado Children's Hospital; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Medical City Dallas; 🇺🇸 Dallas, Texas, United States

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Schneider Children's Medical Center of Israel; 🇮🇱 Petah Tikva, Israel

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States