RECRUITING

ALTERRA Post-Approval Study

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Conditions

Pulmonary Valve InsufficiencyComplex Congenital Heart DefectTetralogy of FallotPulmonary RegurgitationRVOT AnomalyAlterra prestentSAPIEN 3Pulmonic Delivery SystemTranscatheter pulmonary valve replacementTranscatheter pulmonary valve implantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-05-12
Study Completion:2034-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05378386

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Native or surgically-repaired RVOT with severe PR
  2. 2. Clinically indicated for pulmonary valve replacement
  3. 3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV
  1. 1. Inability to tolerate an anticoagulation/antiplatelet regimen
  2. 2. Active bacterial endocarditis or other active infections

Contacts and Locations

Study Contact

Edwards THV Clinical Affairs
CONTACT
949-250-2500
THV_CT.gov@Edwards.com

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Rady's Children's Hospital
San Diego, California, 92123
United States
Stanford University
Stanford, California, 94305
United States
Colorado Children's Hospital
Aurora, Colorado, 80045
United States
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University in St. Louis
Saint Louis, Missouri, 63130
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University
New York, New York, 10032
United States
Duke University
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Medical City Dallas
Dallas, Texas, 75230
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-12
Study Completion Date2034-12

Study Record Updates

Study Start Date2022-05-12
Study Completion Date2034-12

Terms related to this study

Keywords Provided by Researchers

  • Alterra prestent
  • SAPIEN 3
  • Pulmonic Delivery System
  • Transcatheter pulmonary valve replacement
  • Transcatheter pulmonary valve implantation

Additional Relevant MeSH Terms

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