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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT01454050
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.
* Legal capacity and ability to consent
* Signed patient informed consent
In addition for HF-T devices:
* Bipolar LV-lead with a min. distance of 15 mm between tip and ring
* True bipolar RV lead
Exclusion Criteria:
* Standard contraindication for single, dual, or triple chamber ICD.
* Age \< 18 years
* Pregnant or breast-feeding woman
* Cardiac surgery planned within the next 6 months
* Life expectancy of less than 6 months
* Participating in any other clinical study of an investigational cardiac drug or device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01454050
Study Brief:
Protocol Section:
NCT01454050