Contact information
Type
Scientific
Primary contact
Prof Paulus Kirchhof
ORCID ID
Contact details
University of Birmingham Centre for Cardiovascular Sciences
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4148855
p.kirchhof@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00215774
Protocol/serial number
AFNET-B11
Study information
Scientific title
Targeted pharmacological reversal of electrical remodeling after cardioversion
Acronym
Flec-SL
Study hypothesis
Targeted, short-term pharmacological reversal of electrical remodeling is not inferior to prevent recurrent AF after cardioversion when compared to standard long-term antiarrhythmic medication.
On 05/10/2009 the following changes were made to the trial record :
1. The target number of participants was changed from 760 to 575.
2. The overall trial end date was changed from 30/06/2008 to 01/05/2011.
On 13/10/2009 the target number of participants was changed from 575 to 635.
Ethics approval
Ethics Committee of Ärztekammer Westfalen-Lippe and the Faculty of Medicine, Westfälischen Wilhelms University of Münster, November 2004, ref: 4 VII Kirchhof
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Atrial fibrillation (AF)
Intervention
Targeted, short-term pharmacological reversal of electrical remodeling is not inferior to prevent recurrent AF after cardioversion when compared to standard long-term antiarrhythmic medication.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Time to first recurrence of persistent AF
Secondary outcome measures
1. Time to first occurrence of a documented relapse of atrial fibrillation
2. Number of patients with persistent AF after 6 months
3. Number and total duration of documented AF episodes
4. Time to termination of trial medication
5. Number of hospitalizations due to atrial fibrillation
6. Number of visits without hospitalization
7. Number of serious adverse events of special interest
8. Evolution of left ventricular function
9. Quality of life
Overall trial start date
01/03/2005
Overall trial end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Documented persistent atrial fibrillation
2. Age of 18 years
3. Documented oral anticoagulation (international normalized ratio [INR] ≥2) for at least three weeks prior to inclusion, or exclusion of left atrial thrombi by trans-esophageal echocardiography
4. Written informed consent of the patient
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
635
Participant exclusion criteria
Exclusion criteria are based on the approval information of flecainide and include, among others, patients with known coronary artery disease or typical angina pectoris, patients with depressed left ventricular ejection fraction (<40%), patients with severely depressed renal or hepatic function, patients with overt thyroid disease, and patients with known Brugada syndrome, sinus node dysfunction or higher degree AV nodal block.
Recruitment start date
01/03/2005
Recruitment end date
31/10/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University of Birmingham Centre for Cardiovascular Sciences
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) (Germany)
Sponsor details
Domagkstr. 11
Münster
48149
Germany
+49 (0)251-83- 45341
info@kompetenznetz-vorhofflimmern.de
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) with funds of the German Research Foundation (Deutsche Forschunggemeinschaft [DFG]) and the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Meda Pharma (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16290956
2. 2007 publication with some data on the Flec-SL trial: http://www.ncbi.nlm.nih.gov/pubmed/17897924
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22713626
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22986401
5. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23871349
Publication citations
-
Protocol
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, 150, 5, 899, doi: 10.1016/j.ahj.2005.07.020.
-
Results
Kirchhof 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, 380, 9838, 238-246, doi: 10.1016/S0140-6736(12)60570-4.
-
Results
Wyse DG, ACP Journal Club. Short-term was less effective than long-term flecainide for preventing recurrent AF after cardioversion., Ann. Intern. Med., 2012, 157, 6, JC3-9, doi: 10.7326/0003-4819-157-6-201209180-02009.
-
Kirchhof P, Auricchio A, Bax J, Crijns H, Camm J, Diener HC, Goette A, Hindricks G, Hohnloser S, Kappenberger L, Kuck KH, Lip GY, Olsson B, Meinertz T, Priori S, Ravens U, Steinbeck G, Svernhage E, Tijssen J, Vincent A, Breithardt G, Outcome parameters for trials in atrial fibrillation: executive summary., Eur. Heart J., 2007, 28, 22, 2803-2817, doi: 10.1093/eurheartj/ehm358.
-
Results
Apostolakis 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, 168, 4, 3977-3981, doi: 10.1016/j.ijcard.2013.06.090.