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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Left Ventricular Assist Device, Percutaneous Lead Management

Intervention / Treatment
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* Other: Percutaneous Lead Management Kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Percutaneous Lead Management Kit|A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of the wearability and usability of the Percutaneous Lead Management Kit |  | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions to any Percutaneous Lead Management Kit components |  | Up to 6 months | 
| Evidence of driveline infection |  | Up to 6 months | 
| Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization |  | Up to 7 days continuous kit use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoratec, HeartMate II, heart-assist devices, driveline or percutaneous lead management, HeartMate II Percutaneous Lead Management