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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT03103503
Eligibility Criteria:
Inclusion Criteria:
* Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
* Able to understand the nature of the registry and provide informed consent
* Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
* Accepts BIOTRONIK Home Monitoring® concept
* Age greater than or equal to 18 years
Exclusion Criteria:
* Enrolled in any investigational cardiac device trial
* Enrolled in BIOTRONIK's QP ExCELs lead study
* Planned cardiac surgical procedures or interventional measures within the next 6 months
* Expected to receive heart transplantation or ventricular assist device within 1 year
* Life expectancy of less than 1 year
* Patients reporting pregnancy at the time of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03103503
Study Brief:
Protocol Section:
NCT03103503