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 |
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
We found this trial at
91
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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166 Stoneridge Drive
Columbia, South Carolina 29210
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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