ALTERRA Post-Approval Study

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Regurgitation; RVOT Anomaly; Complex Congenital Heart Defect
• Intervention / Treatment: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel
    • Schneider Children's Medical Center of Israel
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Colorado Children's Hospital
  • Florida
    • Gainesville, Florida, United States, 32669
      • UF Health Shands Hospital
    • Tampa, Florida, United States, 33607
      • St. Joseph's Children's Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University in St. Louis
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • Children's Memorial Hermann Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TPVR; Transcatheter Pulmonary Valve Replacement	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): September 25, 2025
• Study Completion (Estimated): July 1, 2035

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: SAPIEN 3; Alterra prestent; Pulmonic Delivery System; Transcatheter pulmonary valve replacement; Transcatheter pulmonary valve implantation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tetralogy of Fallot; Pulmonary Valve Insufficiency
• Other Study ID Numbers: 2021-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: Yes