ALTERRA Post-Approval Study

Last updated: March 5, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Pentalogy Of Cantrell

Treatment

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Clinical Study ID

NCT05378386
2021-11
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Inability to tolerate an anticoagulation/antiplatelet regimen

  2. Active bacterial endocarditis or other active infections

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
Phase:
Study Start date:
May 12, 2022
Estimated Completion Date:
July 31, 2035

Study Description

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

Connect with a study center

  • Schneider Children's Medical Center of Israel

    Petah Tikva,
    Israel

    Active - Recruiting

  • Children's of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Rady's Children's Hospital

    San Diego, California 92123
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

  • Colorado Children's Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Advocate Children's Hospital

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Medical City Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Pirmary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.