Clinical trial NCT01577433: Driveline Silicone Skin Interface Registry
Official title: Driveline Silicone Skin Interface (SSI) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Driveline Heart-assisted Device Related Infection
Keywords: HeartMate II
heart-assist device
left ventricular assist device
driveline infection
LVAD
HMII LVAS driveline
silicone portion
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2012-04-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications

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)


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from DL infection events at 12 months after LVAD implantation
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of subjects with infection events
timeFrame: Month 1, 3, 6, and every six months up to 60 months post-enrollment
measure: DL infection events per patient year
timeFrame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
measure: DL tunneling methods or other factors that might reduce risks of DL related infection events
timeFrame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St.Vincent's Hospital and Health Services
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Dallas
country: United States
facility: Baylor Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
Study officials:
affiliation: Abbott Medical Devices
name: David Farrar, PhD
role: STUDY_DIRECTOR
References:
citation: Akhter SA, Ewald GA, Walsh MN, et al. Preliminary driveline infection results from the multicenter silicone-skin-interface (SSI) registry. Abstracts from the ASAIO 59th Annual Conference, p. 61. http://journals.lww.com/asaiojournal/Documents/ASAIO%20Abstracts%202013.pdf