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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01919320
Eligibility Criteria:
Inclusion Criteria:
* Implanted with the TAH-t
* Patient or their legal representative has signed an informed consent (ICF) form for INTERMACS Registry participation or waiver of consent has been approved at the implanting institution.
Exclusion Criteria:
* Patient or legal guardian has not signed an ICF for INTERMACS Registry participation, if required at the institution.
* Patient is incarcerated.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01919320
Study Brief:
Protocol Section:
NCT01919320