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ALTERRA Post-Approval Study
Sponsor: Edwards Lifesciences
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
Official title: Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2022-05-12
Completion Date
2035-07
Last Updated
2025-11-04
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (24)
Children's of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Rady Children's Hospital
San Diego, California, United States
Stanford University
Stanford, California, United States
Colorado Children's Hospital
Aurora, Colorado, United States
UF Health Shands Hospital
Gainesville, Florida, United States
St. Joseph's Children's Hospital
Tampa, Florida, United States
Advocate Children's Hospital
Oak Lawn, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University in St. Louis
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Medical City Dallas
Dallas, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Schneider Children's Medical Center of Israel
Petah Tikva, Israel