Effectiveness Study of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01856075
• Lead Sponsor: La-ser Europe Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1015

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 Renal insufficiency/failure	3 month; 6 month; 12-18 month
Change from baseline Torsade de pointes	3 month; 6 month; 12-18 month
Change from baseline Liver injury/toxicity	3 month; 6 month; 12-18 month
Change from baseline Myocardial infarction	3 month; 6 month; 12-18 month
Change from baseline Cardiovascular hospitalisation	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 Clinical progression to heart failure and left ventricular systolic dysfunction	3 month; 6 month; 12-18 month
Change from baseline Cerebrovascular accident/Stroke	3 month; 6 month; 12-18 month

Trial Locations

Locations (1)

Praxis fuer Kardiologie, Im Muehlenbach 2B; 🇩🇪 Bonn, Germany