150
Participants
Start Date
May 12, 2022
Primary Completion Date
July 31, 2025
Study Completion Date
July 31, 2035
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).
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Columbia University, New York
RECRUITING
UPMC Children's Hospital of Pittsburgh, Pittsburgh
WITHDRAWN
University of Virginia, Charlottesville
RECRUITING
Duke University, Durham
RECRUITING
UF Health Shands Hospital, Gainesville
RECRUITING
St. Joseph's Children's Hospital, Tampa
RECRUITING
Children's of Alabama, Birmingham
RECRUITING
Le Bonheur Children's Hospital, Memphis
RECRUITING
Nationwide Children's Hospital, Columbus
RECRUITING
Cincinnati Children's Hospital, Cincinnati
WITHDRAWN
Mayo Clinic, Rochester
RECRUITING
Advocate Children's Hospital, Oak Lawn
RECRUITING
Washington University in St. Louis, St Louis
RECRUITING
Arkansas Children's Hospital, Little Rock
RECRUITING
Medical City Dallas, Dallas
RECRUITING
Children's Memorial Hermann Hospital, Houston
RECRUITING
Texas Children's Hospital, Houston
RECRUITING
Colorado Children's Hospital, Aurora
RECRUITING
Primary Children's Hospital, Salt Lake City
RECRUITING
Cedars Sinai Medical Center, Los Angeles
RECRUITING
Rady's Children's Hospital, San Diego
RECRUITING
Stanford University, Stanford
RECRUITING
Seattle Children's Hospital, Seattle
RECRUITING
Boston Children's Hospital, Boston
RECRUITING
Schneider Children's Medical Center of Israel, Petah Tikva
Lead Sponsor
Edwards Lifesciences
INDUSTRY