Overview

This trial is active, not recruiting.

Condition driveline heart-assisted device related infection
Sponsor Thoratec Corporation
Start date May 2012
End date July 2018
Trial size 400 participants
Trial identifier NCT01577433, TC11282011

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)

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Freedom from DL infection events at 12 months after LVAD implantation
time frame: 12 Months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Driveline Silicone Skin Interface (SSI) Registry
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.