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 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT01613092
Eligibility Criteria:
Inclusion Criteria:
* \> 18 years
* received one of the following procedures:
1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)
2. new cardiac resynchronization therapy device implant (pacemaker or ICD)
Exclusion Criteria:
* life expectancy \< 12 months in the opinion of the local investigator.
* allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
* allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
* pre-operative identification that the patient has infection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01613092
Study Brief:
Protocol Section:
NCT01613092