Driveline Silicone Skin Interface Registry

Abbott Medical Devices400 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Driveline Heart-assisted Device Related Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Yale New Haven Hospital

New Haven, Connecticut, United States

Tampa General Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

Freedom from DL infection events at 12 months after LVAD implantation

Time frame: 12 Months

Secondary Outcomes

Percentage of subjects with infection events

Time frame: Month 1, 3, 6, and every six months up to 60 months post-enrollment

DL infection events per patient year

Time frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment

DL tunneling methods or other factors that might reduce risks of DL related infection events

Time frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment

Data from ClinicalTrials.gov

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