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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01485666
First received: December 1, 2011
Last updated: September 26, 2013
Last verified: September 2013

December 1, 2011
September 26, 2013
May 2012
August 2013   (final data collection date for primary outcome measure)
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01485666 on ClinicalTrials.gov Archive Site
  • Incidence of adverse reactions to any Percutaneous Lead Management Kit components [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Evidence of driveline infection [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization [ Time Frame: Up to 7 days continuous kit use ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Ventricular Assist Device clinic

  • Left Ventricular Assist Device
  • Percutaneous Lead Management
Other: Percutaneous Lead Management Kit
A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization
Other Names:
  • Thoratec
  • HeartMate II
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01485666
TC06072011-1
No
Thoratec Corporation
Thoratec Corporation
Not Provided
Not Provided
Thoratec Corporation
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP