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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02326402
Eligibility Criteria:
Inclusion Criteria:
1. Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)
2. Age \>= 18
3. Patient (or legally authorized representative \[LAR\]) has signed informed consent
Exclusion Criteria:
1. Patient is incarcerated (prisoner)
2. Participation in a clinical trial of an investigational drug or device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02326402
Study Brief:
Protocol Section:
NCT02326402