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

2014-08-27 03:13:15 | BioPortfolio

Summary

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Atrial Fibrillation

Intervention

DRONEDARONE, PLACEBO DRONEDARONE

Status

Not yet recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:15-0400

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PubMed Articles [1927 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).

Long-term changes in the electrophysiological parameters and/or anatomical structures of the HEART ATRIA that result from prolonged changes in atrial rate, often associated with ATRIAL FIBRILLATION or long periods of intense EXERCISE.

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.

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