Skip to main content
OpenTrials
Completed

NCT Number: NCT01485666

Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study

The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Left Ventricular Assist Device Percutaneous Lead Management

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent form
  • 16 years of age or older
  • Supported by HeartMate II LVAD continuously for at least 6 months and not currently hospitalized
  • Will continue on LVAD support for at least another 30 days
  • No driveline or systemic infection
  • Willing and able to perform kit dressing changes at least once every 7 days for 30 days
  • Can fill out study forms
  • Can use a digital camera
  • Willing to return to clinic for final study visit in 30 days

Exclusion criteria

  • High risk for non-compliance
  • Ongoing mechanical circulatory support other than HeartMate II LVAD
  • Sensitivity to kit components
  • Skin condition that may react to kit component adhesives
  • Already using all components of Percutaneous Lead Management Kit

Treatment and study plan

Percutaneous Lead Management Kit

Other

A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization

Other names: Thoratec, HeartMate II

Primary outcomes

  1. Demonstration of the wearability and usability of the Percutaneous Lead Management Kit

    Time frame: Up to 30 days

Secondary outcomes

  1. Incidence of adverse reactions to any Percutaneous Lead Management Kit components

    Time frame: Up to 6 months

  2. Evidence of driveline infection

    Time frame: Up to 6 months

  3. Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization

    Time frame: Up to 7 days continuous kit use

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Corporation

Registry information

Official study title

Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol

Acronym: RESIST

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2011
Registry last updated
Jun 24, 2022

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.