Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01485666
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01485666
Study Brief:
Protocol Section:
NCT01485666