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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with dronedarone | Patients treated with dronedarone at inclusion | ||
| Patients treated with other antiarrhythmic drugs of interest | The antiarrhythmic drugs of interest to which dronedarone will be compared are:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This is an international observational multicentre study to be conducted in the following four countries: Germany, Spain, Italy and USA. Patients will be will be recruited from cardiology clinics, both hospital and non-hospital based, depending on particulars of treatment pathway of ppAF patients in each country.
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| Name | Affiliation | Role |
|---|---|---|
| Artak Khachatryan, PhD | LA-SER Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis fuer Kardiologie, Im Muehlenbach 2B | Bonn | 53127 | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |