Status:
COMPLETED
Flecainide-Short Long Study (Flec-SL)
Lead Sponsor:
Atrial Fibrillation Network
Collaborating Sponsors:
German Federal Ministry of Education and Research
Meda Pharmaceuticals
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A randomized trial to test the hypothesis that short-term pharmacological reversal of electrical remodeling after cardioversion is equally efficient to prevent recurrent atrial fibrillation as standar...
Detailed Description
Details of the trial are described in a design paper published in the American Heart Journal (1). Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with approximately one milli...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 enrollment. 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 Fachinformation 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))
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT00215774
Start Date
March 1 2005
End Date
March 1 2011
Last Update
September 11 2012
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