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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT05130268
Eligibility Criteria:
Inclusion Criteria:
1. Age \>=21 years.
2. First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days).
3. Electrocardiographic documentation of atrial fibrillation.
4. Estimated life expectancy of at least 1 year.
5. Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
1\. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (\>7 days) antiarrhythmic drug therapy.
3\. Planned cardiothoracic surgery. 4. New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks.
5\. Patients with reduced ejection fraction (LVEF ≤40%). 6. Permanent atrial fibrillation. 7. Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men.
8\. Bradycardia with a resting heart rate \< 50 bpm 9. PR interval \>280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device.
10\. Corrected QT interval \>=500 msec. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05130268
Study Brief:
Protocol Section:
NCT05130268