Clinical Trial: Driveline Silicone Skin Interface Registry
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Driveline Silicone Skin Interface (SSI) Registry
Brief Summary: 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)
Detailed Summary:
Sponsor: Thoratec Corporation
Current Primary Outcome: Freedom from DL infection events at 12 months after LVAD implantation [ Time Frame: 12 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: St. Jude Medical
Dates:
Date Received: April 11, 2012
Date Started: May 2012
Date Completion: December 2018
Last Updated: December 6, 2016
Last Verified: December 2016
