The Use of Flecainide for Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the trial and error approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

Detailed Description
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Study synopsis for the Tambocor Prospective study Inclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation. Ethics: Informed Concent prior to inclusion. Follow up after baseline: 4 visits during 12 month. End points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide. Evaluated parameters: 12 lead ECG, ECHO: LA, LV, HV strain , Dynamic Heart model: LV and RV. The follow up visits: Baseline: Normal ECHO after the first dose of flecainide, ECG and Questionnaire 4 Weeks: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire. 6 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire. 12 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

Official Title
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Can Global Peak Longitudinal Strain Measurements in Combination With Non-invasive ECG Parameters Predict the Success or Failure of Flecainide Treatment for Atrial Fibrillation Patients?

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: Global peak atrial longitudinal strain and ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation. The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals. Age >18 years Exclusion Criteria: Flecainide treatment with other indication than atrial fibrillation (including atrial flutter). No secure date for treatment start. Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Global peak atrial longitudinal strain and ECG|During the follow-up period the patient will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrythmia free health status | Can we predict who will maintain a normal sinus rhythm prior to initiation of flecainide? treatment start | During the 12 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of AF-free months | Can we improve the number of AF-free months by a better prediction model | During the 12 month follow up | 
| Frequency of side effects | Can we improve the diagnostic accuracy to reduce the frequency of side effects | During the 12 month follow up | 
| Risk of pro-arrhythmias | Can we improve the diagnostic accuracy to reduce risk of pro-arrhythmias | During the 12 month follow up | 
| Mortality | Can we improve the diagnostic accuracy to reduce risk mortality | During the 12 month follow up |