Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Flecainide

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.