ALTERRA Post-Approval Study

Description

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

Conditions

Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly

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Study Overview

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Study Details

Study overview

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

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

ALTERRA Post-Approval Study

Condition
Pulmonary Valve Insufficiency
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama, Birmingham, Alabama, United States, 35233

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

San Diego

Rady's Children's Hospital, San Diego, California, United States, 92123

Stanford

Stanford University, Stanford, California, United States, 94305

Aurora

Colorado Children's Hospital, Aurora, Colorado, United States, 80045

Oak Lawn

Advocate Children's Hospital, Oak Lawn, Illinois, United States, 60453

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Inability to tolerate an anticoagulation/antiplatelet regimen
  • 2. Active bacterial endocarditis or other active infections

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Edwards Lifesciences,

Study Record Dates

2034-12