Driveline Silicone Skin Interface Registry

Completed

Conditions studied: Driveline Heart-assisted Device Related Infection

In brief

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)

Key facts

Study ID

NCT01577433

Run by

Abbott Medical Devices

People needed

400

Starts

2012-05-01

Expected to finish

2018-12-01

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St.Vincent's Hospital and Health Services — Indianapolis, Indiana, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Abbott Northwestern — Minneapolis, Minnesota, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Baylor Medical Center — Dallas, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Sacred Heart Medical Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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