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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT06032195
Eligibility Criteria:
Inclusion Criteria:
* Age from birth to less than18 years
* Recipients awaiting their first transplant
* Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
* written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
* Patient listed on the waiting list for heart transplantation
Exclusion Criteria:
* Patients who have participated within 30 days or are still participating in any other interventional studies
* history of severe organic disease other than concerning the heart
* history/demonstration of HIV antibodies or AIDS
* multiorgan transplantation
* machine-perfused organ
* the explantation team is affiliated to another clinic than transplantation team
* Failing Fontan patients
* Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
* Pregnancy and lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Hours
Maximum Age:
17 Years
Study:
NCT06032195
Study Brief:
Protocol Section:
NCT06032195