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CompletedNCT01577433SSIUpdated Mar 13, 2019

Driveline Silicone Skin Interface Registry

An observational study in Driveline Heart-assisted Device Related Infection, sponsored by Abbott Medical Devices. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Abbott Medical Devices (part of Abbott) · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • 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
03

In context

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Browse Abbott Medical Devices studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
400 participants (actual)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Freedom from DL infection events at 12 months after LVAD implantation

    Time frame: 12 Months

Secondary outcomes

  1. Percentage of subjects with infection events

    Time frame: Month 1, 3, 6, and every six months up to 60 months post-enrollment

  2. DL infection events per patient year

    Time frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment

  3. 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

07

Study locations

15 sites
  • 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
08

References and documents

Publications

  • 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
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Jul 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2012
First posted
Apr 13, 2012
Start
May 2012
Primary completionActual
Jul 2018
CompletionActual
Dec 2018
Last update
Mar 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01577433
Lead sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation
Responsible party
Sponsor
First posted
Apr 13, 2012
Start date
May 2012
Primary completion
Jul 2018
Completion
Dec 2018
Last update
Mar 13, 2019

Study contacts

David Farrar, PhD
study director · Abbott Medical Devices

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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