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Flecainide-Short Long Study (Flec-SL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by German Atrial Fibrillation Network.   Recruitment status was  Recruiting

First Received on September 14, 2005.   Last Updated on December 9, 2005   History of Changes
Sponsor: German Atrial Fibrillation Network
Collaborators: German Federal Ministry of Education and Research
3M
German Research Foundation
Information provided by: German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00215774
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Drug: Flecainid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion.

Resource links provided by NLM:


Further study details as provided by German Atrial Fibrillation Network:

Primary Outcome Measures:
  • time to persistent atrial fibrillation as determined by daily telemetric ECG recordings and verified by Holte ECg recording

Secondary Outcome Measures:
  • time to first symptomatic episode of AF
  • AF burden (number and duration of AF episodes)
  • number of hospitalizations due to AF
  • time to termination of trial medication
  • number of serious adverse events including pro-arrhythmic events
  • quality of life

Estimated Enrollment: 760
Study Start Date: March 2005
Estimated Study Completion Date: April 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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  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))
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215774

Contacts
Contact: Paulus - Kirchhof, PD, Dr.med. ++49(0) 251-83 45160 ext - kirchhp@uni-muenster.de
Contact: Stefan - Orwat, Dr. med. ++49(0) 251-83 48155 ext - orwat@uni-muenster.de

Locations
Germany
University Hospital of Muenster Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48129
Contact: Paulus - Kirchhof, PD, Dr.     ++49-(0)251 83 45160     kirchhp@uni-muenster.de    
Contact: Sabine - Juergensmeyer, Dr.     ++49-(0)251 83 47624     sabine.juergensmeyer@ukmuenster.de    
Principal Investigator: Paulus - Kirchhof, PD, Dr.            
Principal Investigator: Günter - Breithardt, Prof., Dr.            
Sub-Investigator: Stefan - Orwat, Dr.            
Sub-Investigator: Sabine - Juergensmeyer, Dr.            
Sponsors and Collaborators
German Atrial Fibrillation Network
German Federal Ministry of Education and Research
3M
German Research Foundation
Investigators
Principal Investigator: Paulus - Kirchhof, PD, Dr. AFNET, Kompetenznetz Vorhofflimmern
Principal Investigator: Günter - Breithardt, Prof., Dr. AFNET, Kompetenznetz Vorhofflimmern
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00215774     History of Changes
Other Study ID Numbers: AFNET-B11
Study First Received: September 14, 2005
Last Updated: December 9, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Atrial Fibrillation Network:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012