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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT06393920
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 18 years of age or minimum age as required by local regulations.
* Subject has been diagnosed with atrial fibrillation (AF)
* Planned procedure using commercially available PulseSelectâ„¢ PFA System.
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.
Exclusion Criteria:
* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
* Subject with exclusion criteria required by local law.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06393920
Study Brief:
Protocol Section:
NCT06393920