Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT05205551
Eligibility Criteria:
Patients must meet all the following criteria to be eligible for the study:
1. Age 18 or older at the time of informed consent.
2. Enrolled within 60 days following heart transplantation.
3. Prospera™ testing is planned as part of standard clinical care to monitor for and assess transplant rejection.
4. Prospera™ testing is planned to be performed within 60 days (inclusive) following heart transplantation.
5. Selected by their healthcare provider to receive or continue receiving Prospera™ testing as part of their routine transplant management.
6. Willing and able to provide written informed consent.
7. Willing and able to comply with study procedures.
Patients are not eligible for the study if they meet any of the following criteria:
1. Pregnant at the time of signing informed consent.
2. Candidate for multiple solid organ or tissue transplant.
3. History of prior organ or cellular transplantation.
4. Ongoing testing with another allograft dd-cfDNA assessment is planned.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05205551
Study Brief:
Protocol Section:
NCT05205551