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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT06142604
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Noncardiac surgery in the last 30 days requiring an overnight hospital admission;
* Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;
* In AF at the time of randomization; AND,
* Provided written informed consent.
Exclusion Criteria:
* History of AF without normal sinus rhythm documented within 90 days prior to randomization;
* Hemodynamic instability;
* Have any one of the following contraindications to flecainide:
1. known left ventricular ejection fraction ≤ 40%;
2. myocardial infarction within the last 30 days;
3. QRS interval \>140ms;
4. allergy to flecainide;
5. severe uncorrected hypokalemia (\<2.5 mEq/L) or hyperkalemia (\>6.5 mEq/L) at the time of randomization;
6. severe acute liver dysfunction or history of advanced cirrhosis;
7. severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
8. second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;
* Unable to take oral medication;
* Previously enrolled in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06142604
Study Brief:
Protocol Section:
NCT06142604