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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04591366
Eligibility Criteria:
Inclusion Criteria:
1. Patient aged 18
2. Second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket.
3. PADIT risk score ≥ 5
Exclusion Criteria:
1. Unable or unwilling to provide informed consent.
2. De novo device implantation.
3. Active device infection.
4. Iodine allergy
5. Life expectancy less than 2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04591366
Study Brief:
Protocol Section:
NCT04591366