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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT06018818
Eligibility Criteria:
Inclusion Criteria:
* Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept
Exclusion Criteria:
* Planned for conduction system pacing
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Known pregnancy or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation
* Life-expectancy less than 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06018818
Study Brief:
Protocol Section:
NCT06018818