FLIP-AF: Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Flecainide 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
Single 300mg dose of oral flecainide
|
| No Intervention: No flecainide 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. |
Outcome Measures
Primary Outcome Measures
- Recruitment rate [through study completion, an average of six months]
Minimum recruitment rate of at least 1.5 patients per site per month
- Follow-up completion rate [through study completion, an average of six months]
Completion rate of at least 90%
Eligibility Criteria
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:
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History of AF without normal sinus rhythm documented within 90 days prior to randomization;
-
Hemodynamic instability;
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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;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Population Health Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-FLIPAF