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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01577433
Eligibility Criteria:
Inclusion Criteria:
* Subject has signed the INTERMACS informed consent form
* Subject has signed the SSI registry informed consent form
* Subject age ≥ 18 years
* Subject implanted with a HeartMate II LVAD
* Subject in whom the full length of the velour portion of the percutaneous lead is fully kept under the skin resulting in a silicone skin interface at the skin exit site
* In the prospective study cohort, Subject is planned to be supported with the HeartMate II LVAD for at least 12 months
* In the retrospective study cohort, at the time of enrollment, Subject has been supported with a HeartMate II for at least 10 months
Exclusion Criteria:
* In the retrospective study cohort, Subject is ongoing with long-term right heart mechanical circulatory support (RVAD)
* In the retrospective study cohort, Subject had a post-implant sternal re-entry (for bleeding, etc.) or delayed sternal closure
* In the retrospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
* In the prospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01577433
Study Brief:
Protocol Section:
NCT01577433