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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02158403
Eligibility Criteria:
Inclusion Criteria:
* Subject or legally authorized representative has signed an informed consent form
* Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD)
Exclusion Criteria:
* Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)
* Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02158403
Study Brief:
Protocol Section:
NCT02158403