ALTERRA Post-Approval Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Valve Insufficiency Cardiovascular Abnormalities Cardiovascular Diseases Complex Congenital Heart Defect Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Pulmonary Regurgitation RVOT Anomaly Tetralogy of Fallot

Sex eligibility

All sexes

Study type

Observational

Primary location

Schneider Children's Medical Center of Israel, Petah Tikva, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

Acute Device Success

Time frame: 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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2035
First posted: May 18, 2022
Registry last updated: Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting