Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01485666
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:
NCT01485666
Study Brief:
Protocol Section:
NCT01485666