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Feasibility
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flecainide | Experimental | 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. |
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| No flecainide | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flecainide | Drug | Single 300mg dose of oral flecainide |
|
| 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 |
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Inclusion Criteria:
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:
Unable to take oral medication;
Previously enrolled in the trial.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |