RECRUITING
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Trifecta-Heart cfDNA-MMDx Study
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 from heart transplants.
Conditions:
🦠 Heart Transplant Rejection
🗓️ Study Start (Actual) 1 June 2021
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) July 2027
👥 Enrollment (Estimated) 300
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Little Rock, Arkansas, United States
📍 Los Angeles, California, United States
📍 Los Angeles, California, United States
📍 W. New York, New Jersey, United States
📍 Bronx, New York, United States
📍 Dallas, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Darlinghurst, Australia
📍 Vienna, Austria
📍 Edmonton, Alberta, Canada
📍 Prague, Czechia
📍 Bologna, Italy
📍 Zabrze, Poland
📍 La Coruna, Spain
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * Patients will be excluded from the study if they decline participation
    • * Are unable to give informed consent.
    • * Recipients of multiple organs.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 January 2021
  • First Submitted that Met QC Criteria 11 January 2021
  • First Posted 13 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 June 2024
  • Last Update Posted 24 June 2024
  • Last Verified June 2024
I'm interested ...!!