Status:
COMPLETED
Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation
Lead Sponsor:
Natera, Inc.
Conditions:
Heart Transplant
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation. All subjects will fol...
Detailed Description
Subjects will undergo surveillance monitoring for rejection per the institution's standard clinical care schedule after transplant. Surveillance procedures may include EMB, imaging such as echocardiog...
Eligibility Criteria
Inclusion
- Age 18 years or older at the time of signing informed consent.
- Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
- Able to read, understand, and provide written informed consent.
- Able and willing to comply with the study visit schedule, study procedures, and study requirements.
Exclusion
- Concurrent multiple solid organ or tissue transplants.
- Prior history of any organ or cellular transplantation.
- Pregnant.
Key Trial Info
Start Date :
December 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2024
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT05309382
Start Date
December 12 2022
End Date
October 2 2024
Last Update
October 29 2024
Active Locations (9)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California, San Diego
San Diego, California, United States, 92103
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611