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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05560958
Eligibility Criteria:
Inclusion Criteria:
* Indication for diagnostic or therapeutic EP intervention
* EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories:
* BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)
* BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)
* BIOTRONIK transseptal sheath (Senovo Bi-Flex)
* BIOTRONIK EP product is planned to be used within its intended purpose
* 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
Exclusion Criteria:
* Age less than 18 years
* Pregnant or breastfeeding
* Prior participation in this study with performed EP procedure
* Participation in an interventional clinical investigation in parallel to the BIO\|COLLECT.EP study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05560958
Study Brief:
Protocol Section:
NCT05560958