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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT04438395
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be aged \>18 years.
2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
5. Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.
Exclusion Criteria:
1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Patient had experienced previous stroke (TIA or CVA).
4. Thrombi detected in the heart.
5. Known marked valvular insufficiency (moderate-severe and severe)
6. Life expectancy less than 12 months.
7. Known severe renal insufficiency (stages G4 and G5, characterized by severe reduction in GFR \[15-29 ml/min/1.73 m2\] and GFR \[\<15 ml/min/1.73 m2\], respectively).
8. Subjects that according to the clinical judgment of the caring physician do not fit for the study.
9. Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04438395
Study Brief:
Protocol Section:
NCT04438395