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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07360158
Eligibility Criteria:
Inclusion Criteria:
* Standard indication for ICD or CRT-D therapy according to clinical guidelines
* Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker
* Ability to understand the nature of the study.
* Ability and willingness to perform all on-site follow-up visits at the study site.
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept.
Exclusion Criteria:
* For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia
* For VR-T DX and CRT-DX: Patients requiring atrial pacing
* Planned for His-Bundle-Pacing
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Pregnant or breast feeding.
* Age less than 18 years.
* Participation in an interventional clinical investigation in parallel to this study. ,
* Life-expectancy less than 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT07360158
Study Brief:
Protocol Section:
NCT07360158