Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers



Status:Archived
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2010
End Date:August 2011

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A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers


The primary Objective of this study is to:

- Evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (percent of time in
which a subject is in AF) based on electrogram (EGM) data in subjects with a permanent
pacemaker

The secondary Objectives of this study are to:

- Evaluate the effects on AF pattern characteristics: number of episodes, duration, and
ventricular rate during AF

- Evaluate the effects on subject-perceived AF burden and symptom severity as reported by
subjects using the Atrial Fibrillation Severity Scale (AFSS)

- Evaluate the relationships between AF burden and subject-perceived AF burden as well as
AF symptom severity as reported on the AFSS

- Evaluate the incidence of electrical cardioversion (or overdrive pacing) during
treatment

- Evaluate the incidence of persistent AF during treatment

- Evaluate the safety of dronedarone



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