Effectiveness Study of Atrial Fibrillation

Study Overview
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Brief Summary
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This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.

Official Title
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Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years old or above Patient with paroxysmal or persistent atrial fibrillation Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug) Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment Patient with at least 6 months of medical and treatment information prior to the start of the index drug Patient able to answer the telephone interview in a language of the participating country: English, German, Italian or Spanish (with or without proxy). Exclusion Criteria: Patient with heart failure (NYHA class IV) Patient with permanent Atrial Fibrillation Patient with psychiatric conditions preventing the participation to the study according to the physician

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with dronedarone<br>Patients treated with dronedarone at inclusion | |
| Patients treated with other antiarrhythmic drugs of interest<br>The antiarrhythmic drugs of interest to which dronedarone will be compared are: Class 1a/1c antiarrhythmics Sotalol Amiodarone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Recurrence of Atrial Fibrillation | Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up | 3 month; 6 month; 12-18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Cardiovascular hospitalisation |  | 3 month; 6 month; 12-18 month | 
| Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Progression to permanent Atrial Fibrillation |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Congestive heart failure |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Interstitial pulmonary disease |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Liver injury/toxicity |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Renal insufficiency/failure |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Cerebrovascular accident/Stroke |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Myocardial infarction |  | 3 month; 6 month; 12-18 month | 
| Change from baseline Torsade de pointes |  | 3 month; 6 month; 12-18 month | 
| Death | Assessed at each follow-up: 3 month, 6 month, and 12-18 month | 3 month; 6 month; 12-18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Effectiveness, Atrial Fibrillation, Dronedarone, Cohort