Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Dronedarone, Cohort, Effectiveness
Brief summary
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.
Interventions
None listed
Sponsors
La-ser Europe Limited
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Recurrence of Atrial Fibrillation | 3 month; 6 month; 12-18 month | Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Cardiovascular hospitalisation | 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 | 3 month; 6 month; 12-18 month | Assessed at each follow-up: 3 month, 6 month, and 12-18 month |
| Change from baseline Liver injury/toxicity | 3 month; 6 month; 12-18 month | — |
Countries
Germany
Outcome results
None listed