Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DRUGFlecainide
Sponsors
3M
MEDA Pharma GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or Self ECG unit recording. | — |
Secondary
| Measure | 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 | — |
| Number of emergency admissions due to AF recurrence | — |
| Cardiac Safety | — |
Countries
Belgium, Bulgaria, France, Germany, Netherlands, Romania, Spain
Outcome results
None listed