A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy (NCT06414603)
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy (ACES-EMB)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
- The Prospera™ Test (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
- University of California, San Diego — San Diego, California
- University of Colorado — Aurora, Colorado
- Mayo Clinic — Jacksonville, Florida
- AdventHealth Orlando — Orlando, Florida
- Kansas University Medical Center — Kansas City, Kansas
- Brigham and Women's Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- NYU Langone Health — New York, New York
- Duke University — Durham, North Carolina
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- University of Texas, Southwestern Medical Center — Dallas, Texas
- Baylor Scott White - Temple — Temple, Texas
- University of Utah — Salt Lake City, Utah
- Inova Schar Heart and Vascular Institute — Falls Church, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Transplant Failure and Rejection
- Allograft Dysfunction in Heart Transplant — La Jolla, California
Explore by condition: All Heart Transplant Failure and Rejection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.