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ISRCTN
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ISRCTN62728743
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ClinicalTrials.gov identifier
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Public title
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Targeted pharmacological reversal of electrical remodeling after cardioversion
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Scientific title
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Acronym
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Flec-SL
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Serial number at source
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AFNET-B11
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Study hypothesis
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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.
Please note that the following amendments have been made to this trial record as of 05/10/2009:
1. The target number of participants was updated from 760 to 575
2. The anticipated end date of this trial has been updated from 30/06/2008 to 01/05/2011.
Please note that, as of 13/10/2009, the target number of participants was updated from 575 to 635.
As of 01/09/2010, the actual participant recruitment end date was 31/10/2009.
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Lay summary
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Ethics approval
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Ethics Committee of Ärztekammer Westfalen-Lippe and the Faculty of Medicine, Westfälischen Wilhelms University of Münster, approved in November 2004 (ref: 4 VII Kirchhof)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Atrial Fibrillation (AF)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/03/2005
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Anticipated end date
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01/05/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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635
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Interventions
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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.
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Primary outcome measure(s)
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Time to first recurrence of persistent AF
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Secondary outcome measure(s)
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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
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Sources of funding
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1. 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)
2. 3M Medica (Germany)
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Trial website
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Publications
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2005 potocol in http://www.ncbi.nlm.nih.gov/pubmed/16290956
2007 publication with some data on the Flec-SL trial: http://www.ncbi.nlm.nih.gov/pubmed/17897924
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Contact name
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Dr
Paulus
Kirchhof
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Address
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Department of Cardiology and Angiology
University of Münster
Albert-Schweitzer Straße 33
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City/town
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Münster
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Zip/Postcode
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48149
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Country
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Germany
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Tel
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+49 (0)251 83 481 85 or 83 485 0
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Fax
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+49 (0)251 83 478 64
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Email
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kirchhp@uni-muenster.de
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Sponsor
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German Atrial Fibrillation competence NETwork (AFNET) (Kompetenznetz Vorhofflimmern) (Germany)
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Address
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Domagkstr. 11
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City/town
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Münster
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Zip/Postcode
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48149
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Country
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Germany
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Tel
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+49 (0)251-83- 45341
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Fax
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+49 (0)251 83 45343
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Email
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info@kompetenznetz-vorhofflimmern.de
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Sponsor website:
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http://www.kompetenznetz-vorhofflimmern.de/
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Date applied
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06/04/2005
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Last edited
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01/09/2010
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Date ISRCTN assigned
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02/08/2005
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