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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flecainide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of AF recurrences during the treatment period | ||
| Total number of patients in sinus rhythm at the end of the study | ||
| AF Burden |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof E Aliot | CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imeldaziekenhuis, Imeldalaan 9 | Bonheiden | 2820 | Belgium | |||
| Hôpital St.-Joseph, Rue de la Duchère 6 |
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| Number of emergency admissions due to AF recurrence |
| Cardiac Safety |
| 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 | Rousse | 7002 | Bulgaria |
| Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd | Sofia | 1202 | Bulgaria |
| National Cardiology Hospital EAD, 65 Konjovitza Str. | Sofia | 1309 | Bulgaria |
| Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str | Sofia | 1431 | 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 |
| Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd | Sofia | 1606 | 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 | Bucharest | 011461 | Romania |
| Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2 | Bucharest | 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. | Timișoara | 300203 | Romania |
| Hospital Universitario de Getafe, Carretera de toledo | Madrid | 28905 | Spain |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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