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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT05477602
Eligibility Criteria:
Inclusion Criteria:
* Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
* Male or non-pregnant female aged ≥ 21 years.
* Able and willing to provide written informed consent prior to any clinical investigation related procedure.
Exclusion Criteria:
* Current participation in another investigational drug or device study that interferes with this study.
* 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 less than 12 month, in the opinion of the Investigator.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT05477602
Study Brief:
Protocol Section:
NCT05477602