Flecainide-Short Long Study (Flec-SL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00215774 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : September 11, 2012
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Condition or disease | Intervention/treatment | Phase |
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Atrial Fibrillation | Drug: Flecainide | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 760 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Targeted Pharmacological Reversal of Electrical Remodeling After Cardioversion. |
Study Start Date : | March 2005 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
No Intervention: No antiarrhythmic treatment
Control group
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Experimental: B-Flecainide treatment
4 weeks treatment with flecainide
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Drug: Flecainide
Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
Other Name: Flecainide in all its approved oral preparations |
Experimental: C-Flecainide treatment
6 months flecainide treatment
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Drug: Flecainide
Flecainide 2 - 3 x 100 mg/d The main difference between the two active therapy groups is the duration of treatment.
Other Name: Flecainide in all its approved oral preparations |
- time to persistent atrial fibrillation as determined by daily telemetric ECG recordings and verified by Holter ECG recording [ Time Frame: primary endpoint ]
- time to first symptomatic episode of AF [ Time Frame: end of trial ]
- AF burden (number and duration of AF episodes) [ Time Frame: end of trial ]
- number of hospitalizations due to AF [ Time Frame: end of trial ]
- time to termination of trial medication [ Time Frame: end of trial ]
- number of serious adverse events including pro-arrhythmic events [ Time Frame: end of trial ]
- quality of life [ Time Frame: end of trial ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 of more than 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))

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215774
Principal Investigator: | P Kirchhof, Prof | AFNET, Kompetenznetz Vorhofflimmern | |
Principal Investigator: | G Breithardt, Prof | AFNET, Kompetenznetz Vorhofflimmern |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Paulus Kirchhof, Prof MD, Atrial Fibrillation Network |
ClinicalTrials.gov Identifier: | NCT00215774 |
Other Study ID Numbers: |
AFNET-B11 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | September 11, 2012 |
Last Verified: | September 2012 |
Atrial fibrillation |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Flecainide |
Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |