Effectiveness Study of Atrial Fibrillation

NCT ID: NCT01856075

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1015 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-08-31

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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Groups

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Patients treated with dronedarone

Patients treated with dronedarone at inclusion

No interventions assigned to this group

Patients treated with other antiarrhythmic drugs of interest

The antiarrhythmic drugs of interest to which dronedarone will be compared are:

* Class 1a/1c antiarrhythmics
* Sotalol
* Amiodarone

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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La-ser Europe Limited

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Artak Khachatryan, PhD

Role: STUDY_DIRECTOR

LA-SER Europe

Locations

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Praxis fuer Kardiologie, Im Muehlenbach 2B

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Sanofi-EFFECT-AF

Identifier Type: -

Identifier Source: org_study_id

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