Effectiveness Study of Atrial Fibrillation

La-ser Europe Limited1,015 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,015

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Praxis fuer Kardiologie, Im Muehlenbach 2B

Bonn, Germany

Outcomes

Primary Outcomes

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