Status:
RECRUITING
Trifecta-Heart cfDNA-MMDx Study
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Natera, Inc.
One Lambda
Conditions:
Heart Transplant Rejection
Eligibility:
All Genders
Brief Summary
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies...
Detailed Description
The current standard for assessment of rejection in heart transplants is an endomyocardial biopsy (EMB) interpreted by histology according to ISHLT guidelines. This has considerable error rates, many ...
Eligibility Criteria
Inclusion
- All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study.
- Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent.
Exclusion
- Patients will be excluded from the study if they decline participation
- Are unable to give informed consent.
- Recipients of multiple organs.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04707872
Start Date
June 1 2021
End Date
July 1 2027
Last Update
November 20 2025
Active Locations (12)
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1
Baptist Health Institute for Research and Innovation
Little Rock, Arkansas, United States, 72205
2
Tampa General Hospital, 409 Bayshore Blvd.
Tampa, Florida, United States, 33606
3
Columbia University Medical Center, Columbia Interventional Cardiovascular Care
West New York, New Jersey, United States, 10032
4
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL
The Bronx, New York, United States, 10467