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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT00599261
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or greater
2. Willingness to provide written informed consent
3. Subjects presenting for any of the following:
1. pacemaker/ICD generator change
2. pacemaker/ICD lead replacement
3. pacemaker/ICD lead revision
4. pacemaker/ICD upgrades
Exclusion Criteria:
1. Age less than 18 years
2. Unwillingness to provide written informed consent
3. Subjects unable to give consent
4. Pregnant or nursing women
5. Patients who have undergone pocket revision or manipulation less than 365 days prior
6. Patients who have undergone pacemaker or ICD implantation less than 365 days prior
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00599261
Study Brief:
Protocol Section:
NCT00599261