Status:
ACTIVE_NOT_RECRUITING
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
Lead Sponsor:
Natera, Inc.
Conditions:
Heart Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled wi...
Detailed Description
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled w...
Eligibility Criteria
Inclusion
- Patients must meet all the following criteria to be eligible for the study:
- Age 18 or older at the time of informed consent.
- Enrolled within 60 days following heart transplantation.
- Prospera™ testing is planned as part of standard clinical care to monitor for and assess transplant rejection.
- Prospera™ testing is planned to be performed within 60 days (inclusive) following heart transplantation.
- Selected by their healthcare provider to receive or continue receiving Prospera™ testing as part of their routine transplant management.
- Willing and able to provide written informed consent.
- Willing and able to comply with study procedures.
- Patients are not eligible for the study if they meet any of the following criteria:
- Pregnant at the time of signing informed consent.
- Candidate for multiple solid organ or tissue transplant.
- History of prior organ or cellular transplantation.
- Ongoing testing with another allograft dd-cfDNA assessment is planned.
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT05205551
Start Date
October 1 2021
End Date
June 30 2027
Last Update
May 22 2025
Active Locations (1)
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1
Natera
San Carlos, California, United States, 94070