Skip to main content
OpenTrials
Completed

NCT Number: NCT01577433

Driveline Silicone Skin Interface Registry

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Driveline Heart-assisted Device Related Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Corporation

Registry information

Official study title

Driveline Silicone Skin Interface (SSI) Registry

Acronym: SSI

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2012
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.