The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in
the prevention of recurrent AF during 9 months of active treatment compared to placebo in
patients with only one documented AF episode.
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Inclusion Criteria:
- History of first symptomatic & documented episode of AF
- LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
Exclusion Criteria:
- History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
- History of ablation for previous AF
- Reversible cause for AF (e. g.thyroid, alcohol, pulmonary embolism, surgery
- Severe symptoms during AF episode (e. g.syncope, chest pain)
- All types of treated arrhythmias other than AF
- History of myocardial infarction (MI), coronary artery disease (CAD), heart failure
(I, II, III and IV of New York Heart Association - NYHA- classification) or valvular
diseases
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or
QTc> 440 ms
- Brugada syndrome
- Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular
block
- 2nd or 3rd degree atrioventricular (AV) block
- Sinus node dysfunction
- Severe hypertension with: Systolic blood pressure ≥ 180 mmHg, and / or· Diastolic
blood pressure ≥ 100 mmHg
- Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
- Implanted pacemaker
- Heart surgery within the last 6 months, or non-stable postoperative condition
- Renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min
(Cockroft and Gault formula
- Uncorrected electrolytic abnormalities
- Have used recently in the last 3 months prior to the inclusion any of the following
treatments: Oral amiodarone, Treatments that lengthen QT interval (e. g.Sultopride,
Drugs causing torsades de pointe (e. g.mizolastine, pentamidine, sparfloxacin,
moxifloxacin, Bupropion
- Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and
DHP from Calcium channel blockers (CCB
Imeldaziekenhuis, Imeldalaan 9, Bonheiden 2820, Belgium
Hôpital St.-Joseph, Rue de la Duchère 6, Gilly B-6060, Belgium
Virga Jesse Ziekenhuis, Stadsomvaart 11, Hassel B - 3500, Belgium
Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105, Leuven B - 3000, Belgium
Clinique Sainte-Elisabet, Place Louise Godin 1, Namur B - 5000, Belgium
Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd, Burgas 8000, Bulgaria
Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str, Pleven 5800, Bulgaria
Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str, Ruse 7002, Bulgaria
Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd, Sofia 1202, Bulgaria
Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str, Sofia 1504, Bulgaria
Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str, Sofia 1606, Bulgaria
Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str, Sofia 1431, Bulgaria
Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd, Sofia 1606, Bulgaria
National Cardiology Hospital EAD, 65 Konjovitza Str., Sofia 1309, Bulgaria
CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd, Varna 9010, Bulgaria
Centre Hospitalier Général, 22, boulevard Général Sibille, Albi 81,000, France
Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill, Arras 62000, France
Philippe CHEMIN, 49 rue du Bocage, Bordeaux 33,200, France
Hopital d'instruction des armées, rue Colonel Fonferrier, Brest 29200, France
Centre Hospitalier Général, 516 avenue de Paris, Cambrai 59,407, France
Patrick GIRAUD, Bat C 132 av Gabriel Péri, Cavaillon 84300, France
André CORBIN, 28 rue du Conte de la Garaye, Dinan 22,100, France
Centre Hospitalier du Leman, 3 avenue de la dame, Evian-thonon 74203, France
Verschuersen Iordanka, 4 rue Béranger, Fontainebleau 77300, France
Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France, Freyming Merlebach 57 804, France
Centre Hospitalier Général, 10 rue de la Charité, Langres 52200, France
Jean Claude GICHTENAERE, 8 quai du Général Leclerc, Martigues 13,500, France
CHI Montfermeil, 10 rue du Gal Leclerc, Montfermeil 93370, France
Résidence Médicale Les Roses, 57, route de Lavérune, Montpellier 34070, France
Patrick KOHAN, 18 rue de la Commanderie, Nancy 54000, France
Centre Hospitalier Regional, 1 rue du Friscaty, Thionville 57126, France
Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne, Toulon 83,100, France
Centre médical, Promenade du petit Languedoc, Villefranche de Rouergue 12200, France
Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9, Bad Berka 99437, Germany
Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -, Bonn D53105, Germany
Klinikum Coburg , Ketschendorfer Str. 33, Coburg D-96450, Germany
Div Cardiology; University Hospital , Leipzigen St 44 -, Magdeburg 39120, Germany
Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,, Münster D-48129, Germany
Kardiologische Praxis, Magirusstr.49, Ulm D 89077, Germany
"Academisch Ziekenhuis Maastricht, P. Debyelaan 25, Maastricht 6229 HX, Netherlands
SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1, Brasov 500157, Romania
"SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1, Bucuresti 011461, Romania
Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2, Bucuresti 020125, Romania
"SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50, Cluj - Napoca 400347, Romania
Centrul de Cardiologie , Str. Tabaci No. 1, Craiova 200642, Romania
CARDIO EXPERT, Str. Romulus, Nr. 62., Timisoara 300203, Romania
Hospital Universitario de Getafe, Carretera de toledo, Madrid 28905, Spain