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 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07344961
Eligibility Criteria:
Inclusion Criteria:
* Participant or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
* Participant has been implanted with the Micra AV2 device or is intended to receive or be treated with an eligible Micra AV2 device as per standard of care.
* Participants with a history of paroxysmal atrial fibrillation undergoing Micra AV2 implantation, as per standard of care.
* Age 18-85 years old with the ability to consent for the procedure
* Participant is consented within the enrollment window of the therapy received, as applicable
* English Speaking
Exclusion Criteria:
* Participant who is, or is expected to be, inaccessible for follow-up
* Participation is excluded by local law
* Participant is currently enrolled or plans to enroll in concurrent drug/device study that may confound the study results
* Participant with persistent/chronic atrial fibrillation
* Prisoner or cognitively impaired due to the study procedures involving independent wearing of the holter monitor for research purposes.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07344961
Study Brief:
Protocol Section:
NCT07344961