Driveline Silicone Skin Interface Registry (SSI)

Abbott

Status: Completed

Conditions: Driveline Heart-assisted Device Related Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01577433

TC11282011

Details and patient eligibility

About

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)

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Control Group

Description:

Historical control HeartMate II BTT and DT data

Prospective and Retrospectively identified SSI

Description:

Prospectively and Retrospectively identified HeartMate II patients where the full length of the velour coated portion of the driveline is tunneled under the skin