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.
Heart Transplant Failure and Rejection
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.
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
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Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
University of California, San Diego, San Diego, California, United States, 92103
University of Colorado, Aurora, Colorado, United States, 80045
Mayo Clinic, Jacksonville, Florida, United States, 32224
Piedmont Healthcare, Atlanta, Georgia, United States, 30309
Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115
University of Michigan, Ann Arbor, Michigan, United States, 48109
Duke University, Durham, North Carolina, United States, 27710
University of Texas, Southwestern Medical Center, Dallas, Texas, United States, 75390
University of Utah, Salt Lake City, Utah, United States, 84112
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Natera, Inc.,
Michael Olymbios, MD, STUDY_DIRECTOR, Natera, Inc.
Josef Stehlik, MD, STUDY_CHAIR, University of Utah
Palak Shah, MD, STUDY_CHAIR, Inova Schar Heart and Vascular
2025-12