Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
150 participants
OBSERVATIONAL
2022-05-12
2035-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TPVR
Transcatheter Pulmonary Valve Replacement
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
2. Clinically indicated for pulmonary valve replacement
3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV
Exclusion Criteria
2. Active bacterial endocarditis or other active infections
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2021-11
Identifier Type: -
Identifier Source: org_study_id
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