The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from DL infection events at 12 months after LVAD implantation