Driveline Silicone Skin Interface Registry
SSI
1 other identifier
observational
400
1 country
15
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 13, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 13, 2019
March 1, 2019
6.2 years
April 11, 2012
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from DL infection events at 12 months after LVAD implantation
12 Months
Secondary Outcomes (3)
Percentage of subjects with infection events
Month 1, 3, 6, and every six months up to 60 months post-enrollment
DL infection events per patient year
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
Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
Study Arms (2)
Control Group
Historical control HeartMate II BTT and DT data
Prospective and Retrospectively identified SSI
Prospectively and Retrospectively identified HeartMate II patients where the full length of the velour coated portion of the driveline is tunneled under the skin
Eligibility Criteria
Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Thoratec Corporationcollaborator
Study Sites (15)
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
St.Vincent's Hospital and Health Services
Indianapolis, Indiana, 46260, United States
University of Iowa Hospital
Iowa City, Iowa, 52242, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Abbott Northwestern
Minneapolis, Minnesota, 55407, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Baylor Medical Center
Dallas, Texas, 75226, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Related Publications (1)
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
BACKGROUND
Study Officials
- STUDY DIRECTOR
David Farrar, PhD
Abbott Medical Devices
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 13, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
March 13, 2019
Record last verified: 2019-03