ALTERRA Post-Approval Study

Recruiting

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

• 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: 2025-07
• Primary Completion: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Study Completion: 2035-07-01

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

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 (26)

UF Health Shands Hospital; 🇺🇸 Gainesville, Florida, United States

St. Joseph's Children's Hospital; 🇺🇸 Tampa, Florida, United States

Le Bonheur Children's Hospital; 🇺🇸 Memphis, Tennessee, United States

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

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

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

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

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

Stanford University; 🇺🇸 Stanford, California, United States

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

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