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

Phase 4

Terminated

Conditions: Atrial Fibrillation

Interventions: Drug: Dronedarone
Drug: Placebo (for Dronedarone)

Registration Number: NCT01135017

Lead Sponsor: Sanofi

Brief Summary: Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.

Secondary objectives were to evaluate:

* the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF;

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

* the incidence of electrical cardioversion (or overdrive pacing) during treatment;

* the safety of dronedarone.

Detailed Description: The maximum duration of the study period for a participant was 18 weeks (approximatively 4.5 months) including up to 4 weeks screening, 12-week Treatment period and a post-treatment follow-up of 2 weeks.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dronedarone	Dronedarone	Dronedarone 400 mg twice a day for 12 weeks
Placebo	Placebo (for Dronedarone)	Placebo (for Dronedarone) twice a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Baseline (before randomization), 4 weeks and 12 weeks after randomization	AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator. AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.

Secondary Outcome Measures

Name	Time	Method
AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	4 weeks and 12 weeks after randomization	AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab
Average Ventricular Rate During AF Episodes	Baseline (before randomization), 4 weeks and 12 weeks after randomization	Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review. The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.
Atrial Fibrillation Severity Scale (AFSS) Scores	Baseline (before randomization) and 12 weeks after randomization	The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm. AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden. AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms.
Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)	12 weeks	Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias. Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study.

Trial Locations

Locations (92): Investigational Site Number 840021
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Riverside, California, United States
Investigational Site Number 840030
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Mesa, Arizona, United States
Investigational Site Number 840014
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Dallas, Texas, United States
Investigational Site Number 840105
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Pittsburgh, Pennsylvania, United States
Investigational Site Number 840029
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Loveland, Colorado, United States
Investigational Site Number 840089
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Littleton, Colorado, United States
Investigational Site Number 840027
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Troy, Michigan, United States
Investigational Site Number 840015
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Birmingham, Alabama, United States
Investigational Site Number 840024
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San Diego, California, United States
Investigational Site Number 840072
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Phoenix, Arizona, United States
Investigational Site Number 840012
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San Antonio, Texas, United States
Investigational Site Number 840083
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Salt Lake City, Utah, United States
Investigational Site Number 840033
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Milwaukee, Wisconsin, United States
Investigational Site Number 840076
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Milwaukee, Wisconsin, United States
Investigational Site Number 840001
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Aurora, Colorado, United States
Investigational Site Number 840042
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Orlando, Florida, United States
Investigational Site Number 840036
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Bronx, New York, United States
Investigational Site Number 840087
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Huntsville, Alabama, United States
Investigational Site Number 840018
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Mobile, Alabama, United States
Investigational Site Number 840013
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Tucson, Arizona, United States
Investigational Site Number 840048
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Phoenix, Arizona, United States
Investigational Site Number 840090
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Laguna Hills, California, United States
Investigational Site Number 840069
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Hot Springs, Arkansas, United States
Investigational Site Number 840070
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Orange, California, United States
Investigational Site Number 840121
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Beverly Hills, California, United States
Investigational Site Number 840068
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Los Angeles, California, United States
Investigational Site Number 840062
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Mission Hills, California, United States
Investigational Site Number 840108
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Newark, Delaware, United States
Investigational Site Number 840106
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Washington, District of Columbia, United States
Investigational Site Number 840045
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Washington, District of Columbia, United States
Investigational Site Number 840058
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Inverness, Florida, United States
Investigational Site Number 840020
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Ft. Myers, Florida, United States
Investigational Site Number 840044
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Jacksonville Beach, Florida, United States
Investigational Site Number 840066
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Jacksonville, Florida, United States
Investigational Site Number 840128
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Jacksonville, Florida, United States
Investigational Site Number 840010
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Clearwater, Florida, United States
Investigational Site Number 840043
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Jacksonville, Florida, United States
Investigational Site Number 840080
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Wellington, Florida, United States
Investigational Site Number 840092
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Normal, Illinois, United States
Investigational Site Number 840016
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Port Charlotte, Florida, United States
Investigational Site Number 840051
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Bloomington, Indiana, United States
Investigational Site Number 840056
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Gainesville, Georgia, United States
Investigational Site Number 840053
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Kansas City, Kansas, United States
Investigational Site Number 840032
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Oak Lawn, Illinois, United States
Investigational Site Number 840110
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Owensboro, Kentucky, United States
Investigational Site Number 840046
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Rockford, Illinois, United States
Investigational Site Number 840102
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Columbia, Maryland, United States
Investigational Site Number 840017
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Lansing, Michigan, United States
Investigational Site Number 840081
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Lapeer, Michigan, United States
Investigational Site Number 840075
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Petoskey, Michigan, United States
Investigational Site Number 840097
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Tupelo, Mississippi, United States
Investigational Site Number 840104
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St Cloud, Minnesota, United States
Investigational Site Number 840055
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St. Louis, Missouri, United States
Investigational Site Number 840037
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Columbia, Missouri, United States
Investigational Site Number 840060
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St Louis, Missouri, United States
Investigational Site Number 840067
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Missoula, Montana, United States
Investigational Site Number 840049
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Reno, Nevada, United States
Investigational Site Number 840026
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Bridgewater, New Jersey, United States
Investigational Site Number 840054
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Reno, Nevada, United States
Investigational Site Number 840093
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Englewood, New Jersey, United States
Investigational Site Number 840086
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Troy, New York, United States
Investigational Site Number 840077
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Kingston, New York, United States
Investigational Site Number 840096
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Mineola, New York, United States
Investigational Site Number 840006
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Buffalo, New York, United States
Investigational Site Number 840041
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Syracuse, New York, United States
Investigational Site Number 840065
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Tulsa, Oklahoma, United States
Investigational Site Number 840084
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Raleigh, North Carolina, United States
Investigational Site Number 840007
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Williamsville, New York, United States
Investigational Site Number 840061
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Wilmington, North Carolina, United States
Investigational Site Number 840008
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Camp Hill, Pennsylvania, United States
Investigational Site Number 840004
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Philadelphia, Pennsylvania, United States
Investigational Site Number 840078
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Phoenixville, Pennsylvania, United States
Investigational Site Number 840009
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Doylestown, Pennsylvania, United States
Investigational Site Number 840019
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Unionville, Pennsylvania, United States
Investigational Site Number 840002
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Rapid City, South Dakota, United States
Investigational Site Number 840130
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Scranton, Pennsylvania, United States
Investigational Site Number 840119
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Greenville, South Carolina, United States
Investigational Site Number 840023
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Wyomissing, Pennsylvania, United States
Investigational Site Number 840114
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Germantown, Tennessee, United States
Investigational Site Number 840118
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Corpus Christi, Texas, United States
Investigational Site Number 840125
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Tyler, Texas, United States
Investigational Site Number 840113
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Danville, Virginia, United States
Investigational Site Number 840082
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Lynchburg, Virginia, United States
Investigational Site Number 840088
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Manassas, Virginia, United States
Investigational Site Number 840003
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Tacoma, Washington, United States
Investigational Site Number 840107
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Tacoma, Washington, United States
Investigational Site Number 840123
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Green Bay, Wisconsin, United States
Investigational Site Number 840047
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Milwaukee, Wisconsin, United States
Investigational Site Number 840035
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Kansas City, Missouri, United States
Investigational Site Number 840099
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Richmond, Virginia, United States
Investigational Site Number 840112
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Richmond, Virginia, United States
Investigational Site Number 840022
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Madison, Wisconsin, United States