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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01628666
Eligibility Criteria:
Inclusion Criteria:
1. Age \>= 18 years
2. Received one of the following procedures:
1. A second or subsequent procedure on the arrhythmia device pocket:
ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement
2. Pocket or lead revision
3. System upgrade (insertion or attempted insertion of leads)
4. New cardiac resynchronization therapy device implant (pacemaker or ICD)
3. Patient is not known to have device infection at the time of the surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01628666
Study Brief:
Protocol Section:
NCT01628666