Flecainide in Atrial Fibrillation - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Atrial Fibrillation

Intervention / Treatment

Drug: Flecainide

Study Type

Interventional

Enrollment

256

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Bonheiden, Belgium, 2820
    - Imeldaziekenhuis, Imeldalaan 9
  - Gilly, Belgium, B-6060
    - Hôpital St.-Joseph, Rue de la Duchère 6
  - Hassel, Belgium, B - 3500
    - Virga Jesse Ziekenhuis, Stadsomvaart 11
  - Leuven, Belgium, B - 3000
    - Regionaal Ziekenhuis Heilig Hart, Naamsestraat 105
  - Namur, Belgium, B - 5000
    - Clinique Sainte-Elisabet, Place Louise Godin 1
Bulgaria
- - Burgas, Bulgaria, 8000
    - Department of Cardiology, MHAT Burgas AD, 73 Stefan Stambolov blvd
  - Pleven, Bulgaria, 5800
    - Cardiology Clinic and ICU, UMHAT "Dr. Georgi Stranski" EAD, 8a Georgi Kochev Str
  - Ruse, Bulgaria, 7002
    - Intensive Therapeutic Department, MHAT Ruse, 2 Nezavosimost str
  - Sofia, Bulgaria, 1202
    - Clinic of cardiology at Second MHAT, 120, Hristo Botev Blvd
  - Sofia, Bulgaria, 1309
    - National Cardiology Hospital EAD, 65 Konjovitza Str.
  - Sofia, Bulgaria, 1431
    - Department of Internal medicine II, University hospital "Aleksandrovska" , 1 G. Sofiyski str
  - Sofia, Bulgaria, 1504
    - Clinic of Cardiology, University Hospital 'Queen Giovanna', 8 Bialo More str
  - Sofia, Bulgaria, 1606
    - Department of Emergency and Intensive care, Military Medical Academy, 3 G. Sofiisky str
  - Sofia, Bulgaria, 1606
    - Intensive care unit - MHATEM "Pirogov" , 21 Totleben Blvd
  - Varna, Bulgaria, 9010
    - CCU, University Hospital "St. Marina" , 1 Hristo Smirnenski Blvd
France
- - Albi, France, 81,000
    - Centre Hospitalier Général, 22, boulevard Général Sibille
  - Arras, France, 62000
    - Hôpital d'Arras service de cardiologie, 57 avenue Wiston Churchill
  - Bordeaux, France, 33,200
    - Philippe CHEMIN, 49 rue du Bocage
  - Brest, France, 29200
    - Hopital d'instruction des armées, rue Colonel Fonferrier
  - Cambrai, France, 59,407
    - Centre Hospitalier Général, 516 avenue de Paris
  - Cavaillon, France, 84300
    - Patrick GIRAUD, Bat C 132 av Gabriel Péri
  - Dinan, France, 22,100
    - André CORBIN, 28 rue du Conte de la Garaye
  - Evian-thonon, France, 74203
    - Centre Hospitalier du Leman, 3 avenue de la dame
  - Fontainebleau, France, 77300
    - Verschuersen Iordanka, 4 rue Béranger
  - Freyming Merlebach, France, 57 804
    - Hôpital de Freyming Merlebach- Service de Cardiologie, 2 rue de France
  - Langres, France, 52200
    - Centre Hospitalier Général, 10 rue de la Charité
  - Martigues, France, 13,500
    - Jean Claude GICHTENAERE, 8 quai du Général Leclerc
  - Montfermeil, France, 93370
    - CHI Montfermeil, 10 rue du Gal Leclerc
  - Montpellier, France, 34070
    - Résidence Médicale Les Roses, 57, route de Lavérune
  - Nancy, France, 54000
    - Patrick KOHAN, 18 rue de la Commanderie
  - Thionville, France, 57126
    - Centre Hospitalier Regional, 1 rue du Friscaty
  - Toulon, France, 83,100
    - Hôpital d'Instruction des Armées Sainte Anne, Boulevard Sainte Anne
  - Villefranche de Rouergue, France, 12200
    - Centre médical, Promenade du petit Languedoc
Germany
- - Bad Berka, Germany, 99437
    - Zentralklinic Bad Berka Gmbr Klinic fur Kardiologie- Leitender Arzt der Avteilung - Rhythmologie und invasive Elektrophysiologie, Robert Koch Allee 9
  - Bonn, Germany, D53105
    - Director of Electrophysiology Laboratory - Department of Medicine - Cardiology- University of Bonn, Sigmund Freud Str 25 -
  - Coburg, Germany, D-96450
    - Klinikum Coburg , Ketschendorfer Str. 33
  - Magdeburg, Germany, 39120
    - Div Cardiology; University Hospital , Leipzigen St 44 -
  - Münster, Germany, D-48129
    - Oberarzt Medizinische Klinik und Poliklinik C IZKF Münster Kompetenznetzt Vorhofflimmern Universitätsklinikum Münster, Albert-Schweitzer-Straße 33,
  - Ulm, Germany, D 89077
    - Kardiologische Praxis, Magirusstr.49
Netherlands
- - Maastricht, Netherlands, 6229 HX
    - "Academisch Ziekenhuis Maastricht, P. Debyelaan 25
Romania
- - Brasov, Romania, 500157
    - SPITALUL JUDETEAN-SECTIA CARDIOLOGIE, BRASOV, Str. Independentei Nr. 1
  - Bucuresti, Romania, 011461
    - "SPITALUL CLINIC DE URGENTA ""ELIAS""-Clinica de Cardiologie, Str. Marasti, Nr. 17, sect 1
  - Bucuresti, Romania, 020125
    - Spitalul Clinic Colentina-Departamentul Cardiologie, str. Stefan cel Mare, nr. 19-21, sector 2
  - Cluj - Napoca, Romania, 400347
    - "SPITALUL CLINIC de RECUPERARE, Str. Viilor Nr.46-50
  - Craiova, Romania, 200642
    - Centrul de Cardiologie , Str. Tabaci No. 1
  - Timisoara, Romania, 300203
    - CARDIO EXPERT, Str. Romulus, Nr. 62.
Spain
- - Madrid, Spain, 28905
    - Hospital Universitario de Getafe, Carretera de toledo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.

Secondary Outcome Measures

Outcome Measure
Total number of AF recurrences during the treatment period
Total number of patients in sinus rhythm at the end of the study
AF Burden
Number of emergency admissions due to AF recurrence
Cardiac Safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEDA Pharma GmbH & Co. KG

Collaborators

3M

Investigators

Principal Investigator: Prof E Aliot, CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 6, 2006

First Submitted That Met QC Criteria