A comparative effectiveness study in heart transplant patients of rejection surveillance with cell-free DNA versus endomyocardial biopsy (ACES-EMB)
NCT ID NCT06414603
Summary
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly. Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.
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Contacts and locations
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Locations
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AdventHealth Orlando
Orlando, Florida, 32804, United States
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Baylor Scott White - Temple
Temple, Texas, 76508, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Duke University
Durham, North Carolina, 27710, United States
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Inova Schar Heart and Vascular Institute
Falls Church, Virginia, 22042, United States
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Kansas University Medical Center
Kansas City, Kansas, 66160, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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NYU Langone Health
New York, New York, 10016, United States
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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University of California, San Diego
San Diego, California, 92103, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Texas, Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
Conditions
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