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

Left Ventricular Assist Device Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01485666
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date May 2012
Completion date August 2013
View Details
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