Flecainide-Short Long Study (Flec-SL)
Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion.
1 other identifier
interventional
760
0 countries
N/A
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 standard long-term antiarrhythmic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Mar 2005
Longer than P75 for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedSeptember 11, 2012
September 1, 2012
4.6 years
September 14, 2005
September 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to persistent atrial fibrillation as determined by daily telemetric ECG recordings and verified by Holter ECG recording
primary endpoint
Secondary Outcomes (6)
time to first symptomatic episode of AF
end of trial
AF burden (number and duration of AF episodes)
end of trial
number of hospitalizations due to AF
end of trial
time to termination of trial medication
end of trial
number of serious adverse events including pro-arrhythmic events
end of trial
- +1 more secondary outcomes
Study Arms (3)
No antiarrhythmic treatment
NO INTERVENTIONControl group
B-Flecainide treatment
EXPERIMENTAL4 weeks treatment with flecainide
C-Flecainide treatment
EXPERIMENTAL6 months flecainide treatment
Interventions
Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
Eligibility Criteria
You may qualify if:
- Documented persistent atrial fibrillation
- Age of 18 years
- Written informed consent of the patient
You may not qualify if:
- 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.
- 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%
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atrial Fibrillation Networklead
- German Federal Ministry of Education and Researchcollaborator
- Meda Pharmaceuticalscollaborator
- German Research Foundationcollaborator
Related Publications (3)
Kirchhof P, Fetsch T, Hanrath P, Meinertz T, Steinbeck G, Lehmacher W, Breithardt G. Targeted pharmacological reversal of electrical remodeling after cardioversion--rationale and design of the Flecainide Short-Long (Flec-SL) trial. Am Heart J. 2005 Nov;150(5):899. doi: 10.1016/j.ahj.2005.07.020.
PMID: 16290956BACKGROUNDKirchhof P, Andresen D, Bosch R, Borggrefe M, Meinertz T, Parade U, Ravens U, Samol A, Steinbeck G, Treszl A, Wegscheider K, Breithardt G. Short-term versus long-term antiarrhythmic drug treatment after cardioversion of atrial fibrillation (Flec-SL): a prospective, randomised, open-label, blinded endpoint assessment trial. Lancet. 2012 Jul 21;380(9838):238-46. doi: 10.1016/S0140-6736(12)60570-4. Epub 2012 Jun 18.
PMID: 22713626RESULTApostolakis S, Haeusler KG, Oeff M, Treszl A, Andresen D, Borggrefe M, Lip GY, Meinertz T, Parade U, Samol A, Steinbeck G, Wegscheider K, Breithardt G, Kirchhof P. Low stroke risk after elective cardioversion of atrial fibrillation: an analysis of the Flec-SL trial. Int J Cardiol. 2013 Oct 9;168(4):3977-81. doi: 10.1016/j.ijcard.2013.06.090. Epub 2013 Jul 18.
PMID: 23871349DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P Kirchhof, Prof
AFNET, Kompetenznetz Vorhofflimmern
- PRINCIPAL INVESTIGATOR
G Breithardt, Prof
AFNET, Kompetenznetz Vorhofflimmern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof MD
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
March 1, 2005
Primary Completion
October 1, 2009
Study Completion
March 1, 2011
Last Updated
September 11, 2012
Record last verified: 2012-09