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

Study Overview
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Brief Summary
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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.

Detailed Description
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FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.

Official Title
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Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial

Conditions
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Atrial Fibrillation, Surgery

Intervention / Treatment
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* Drug: Flecainide


Participation Criteria
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Eligibility Criteria
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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: known left ventricular ejection fraction ≤ 40%; myocardial infarction within the last 30 days; QRS interval >140ms; allergy to flecainide; severe uncorrected hypokalemia (<2.5 mEq/L) or hyperkalemia (>6.5 mEq/L) at the time of randomization; severe acute liver dysfunction or history of advanced cirrhosis; severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flecainide<br>Participants randomized to the flecainide arm will be prescribed a single 300mg dose of oral flecainide, to be given as soon as possible after study randomization. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization. | Drug: Flecainide<br>* Single 300mg dose of oral flecainide<br>|
| No Intervention: No flecainide<br>Participants randomized to the no flecainide arm will not be prescribed flecainide. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Minimum recruitment rate of at least 1.5 patients per site per month | through study completion, an average of six months | 
| Follow-up completion rate | Completion rate of at least 90% | through study completion, an average of six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flecainide