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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT03858361
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years of age.
* Subject signed a written Informed Consent form to participate in the study, prior to any study related procedures.
* Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
* A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
* Subject is deemed amenable to therapeutic ablation for atrial flutter.
Exclusion Criteria:
* Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
* Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
* Patient had experienced previous stroke (TIA or CVA).
* Thrombi detected in the heart.
* Known marked valvar insufficiency.
* Life expectancy less than 12 months.
* Known severe renal insufficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03858361
Study Brief:
Protocol Section:
NCT03858361