Driveline Silicone Skin Interface Registry

Status:	Completed
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - Any
Updated:	3/15/2019
Start Date:	May 2012
End Date:	December 2018

Driveline Silicone Skin Interface (SSI) Registry

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)

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

We found this trial at

sites

Tampa General Hospital

1 Tampa General Cir
Tampa, Florida 33606

(813) 844-7000