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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05047068
Eligibility Criteria:
Inclusion Criteria:
* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
Recipient Exclusion Criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant.
Donor Exclusion Criteria (for DCD Donor Hearts only):
* Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05047068
Study Brief:
Protocol Section:
NCT05047068