Condition category
Circulatory System
Date applied
06/04/2005
Date assigned
02/08/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.kompetenznetz-vorhofflimmern.de/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes