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:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT06877156
Eligibility Criteria:
Inclusion Criteria:
* Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation.
Male or non-pregnant female aged ≥18 years.
Able and willing to provide written informed consent prior to any clinical investigation related procedure
Exclusion Criteria:
* Pregnant or nursing subjects.
* Current participation in another investigational drug or device study that interferes with this study.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Patients who have had a prior ablation procedure
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
* Life expectancy is less than 12 months, in the opinion of the investigator
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06877156
Study Brief:
Protocol Section:
NCT06877156