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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Thoratec Corporation

ClinicalTrials.gov Identifier:

NCT01485666

First received: December 1, 2011

Last updated: May 14, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 1, 2011
Last Updated Date	May 14, 2013
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 2, 2011)	Demonstration of the wearability and usability of the Percutaneous Lead Management Kit [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01485666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 2, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
Official Title ^ICMJE	Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Ventricular Assist Device clinic
Condition ^ICMJE	Left Ventricular Assist Device Percutaneous Lead Management
Intervention ^ICMJE	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
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	70
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01485666
Other Study ID Numbers ^ICMJE	TC06072011-1
Has Data Monitoring Committee	No
Responsible Party	Thoratec Corporation
Study Sponsor ^ICMJE	Thoratec Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Thoratec Corporation
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top