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Assessment of Flecainide to Lower the patent foramen Ovale closure risk of Atrial fibrillation or Tachycardia : AFLOAT study
About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have confirmed that PFO has a causal link with stroke.
In patients with recent cryptogenic stroke, these randomized studies have shown at least 50%-reduction of recurrent neurological events after PFO percutaneous closure compared with medical therapy alone. At the same time, authors identified a higher rate of newly-detected atrial arrhythmias after PFO closure than in medical treatment group. In a recent meta-analysis, 6.6% of PFO closure patients group had a new-onset atrial fibrillation/atrial flutter versus 0.7% in the medical treatment group. Most atrial fibrillation (AF) cases occurred within 1 month after the procedure, a finding that suggests that the procedure itself induces AF. AF is often poorly tolerated and bares the risk of stroke in these patients. When it occurs antiarrhythmic and anticoagulant treatments are required.
The risk of AF reported in these studies in certainly largely underestimated as only symptomatic and recorded episodes of AF have been declared. Patients often report palpitations without a diagnosis of AF made on the ECG or a Holter. Long term ECG monitoring provides more accurate data on AF incidence.
Administration of flecainide has been shown to be effective in preventing AF and may be useful in preventing these AF episodes after PFO closure.
To our knowledge, there is no study assessing the efficacy of any antiarrhythmic drug in the prevention of AF after PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent AF in these patients
Patients will be randomized into 3 groups :