Flec-SL

Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion.

Prospective, randomized, controlled, open label, parallel group multi-center investigator-initiated trial.

Documented persistent atrial fibrillation

Age of 18 years

Documented oral anticoagulation (INR ≥ 2) for at least three weeks prior to inclusion, or exclusion of left atrial thrombi by trans-esophageal echocardiography

Written informed consent of the patient

Current therapy with antiarrhythmic agents of class I and class III other than study medication flecainide. Such antiarrhythmic treatment must be stopped five half lives prior to enrolment. Five half-lives correspond to 48 hours for almost all antiarrhythmic agents. For details regarding a specific agent, this information can be obtained through the internet at www.rote-liste.de or from the information of the specific compound.

Long-term therapy with amiodarone within the last 6 months prior to inclusion

Symptomatic bradycardia or symptomatic sick sinus syndrome unless treated with a permanent pacemaker

Symptomatic higher degree AV nodal block (grade II or III) unless treated with a permanent pacemaker

Brugada syndrome

Typical angina pectoris symptoms at rest or during exercise

Known untreated coronary artery disease with high-degree coronary stenosis (> 80% reduction in luminal diameter)

Myocardial infarction within the last 3 months

Left ventricular ejection fraction of more than 40%

Creatinine clearance < 50 ml/min*1.73 m2 as determined by the Cockroft-Gould formula. The digital data management system will calculate this value for you during the inclusion process. For completeness of documentation, the formula is given below:

Men: Creatinine clearance (ml/min) = (140 – age(years)) * body weight (kg) / (72 * serum creatinine level (mg/dl))

Women: Value for men * 0,85

Manifest hepatic insufficiency

Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)

Females who are pregnant or breast feeding

Females of childbearing potential who are not using a scientifically accepted method of contraception

Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.

Drug addiction or chronic alcohol abuse

Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial

Evidence of an uncooperative attitude

Prolongation of the QRS complex by more than 25% during flecainide treatment (measured as the difference in QRS duration between the baseline ECG and the ECG at cardioversion (34))

Targeted “pharmacological reversal” of atrial remodeling by short-term administration of action potential prolonging antiarrhythmic drugs (4 weeks therapy duration) is equally efficient and potentially safer to prevent recurrent AF after cardioversion when compared to current long-term antiarrhythmic drug therapy.

Short-term treatment with antiarrhythmic drugs after cardioversion is less effective than long-term treatment but can prevent most recurrences of atrial fibrillation.

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Münster, Germany

Birmingham, UK and

Münster, Germany

Kompetenznetz Vorhofflimmern e.V. (Atrial Fibrillation NETwork, AFNET), Münster, Germany