Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
With
Thoratec Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Driveline Silicone Skin Interface Registry
