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
2021-04-13
2030-08-31
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
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
Interventions
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SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
Eligibility Criteria
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Inclusion Criteria
2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
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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University of Alabama
Birmingham, Alabama, United States
Cedars Sinai
Los Angeles, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Advocate Childrens Hospital
Oak Lawn, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Minneapolis Heart
Minneapolis, Minnesota, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mount Sinai
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinatti Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Dell Children's
Austin, Texas, United States
Children's Health Dallas
Dallas, Texas, United States
Primary Children's
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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2020-07
Identifier Type: -
Identifier Source: org_study_id
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