ALTERRA Post-Approval Study

Last updated: October 31, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pentalogy Of Cantrell

Heart Defect

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

    Site Not Available

  • Schneider Children's Medical Center of Israel

    Petah Tikva 293918,
    Israel

    Site Not Available

  • Children's of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Children's of Alabama

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock 4119403, Arkansas 4099753 72202
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Rady's Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Rady Children's Hospital

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Stanford University

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Colorado Children's Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Colorado Children's Hospital

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • UF Health Shands Hospital

    Gainesville, Florida 32669
    United States

    Site Not Available

  • St. Joseph's Children's Hospital

    Tampa, Florida 33607
    United States

    Site Not Available

  • UF Health Shands Hospital

    Gainesville 4156404, Florida 4155751 32669
    United States

    Site Not Available

  • St. Joseph's Children's Hospital

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Advocate Children's Hospital

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Advocate Children's Hospital

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Washington University in St. Louis

    St Louis 4407066, Missouri 4398678 63130
    United States

    Site Not Available

  • 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

    Site Not Available

  • Columbia University

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus 4509177, Ohio 5165418 43205
    United States

    Site Not Available

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15224
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis 4641239, Tennessee 4662168 38103
    United States

    Site Not Available

  • Medical City Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Children's Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Medical City Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Children's Memorial Hermann Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Pirmary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City 5780993, Utah 5549030 84113
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

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