Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054123058
Study information
Scientific title
Acronym
Study hypothesis
Elective DC cardioversion is one of the modalities of treating new atrial fibrillation. The procedure is deemed relatively safe, and immediately effective in most instances. However, there have been few studies comparing the results of early elective DC cardioversion with the results of the use of anti-arrhythmic drugs only as primary modalities of treatment for this condition, and the implications this may have on the incidence of heamodynamic compromise, thrombo-embolic events and hospital stay. The results of this study will help us in making the choice about the safest, quickest and most appropriate modality of treatment for these patients, and this would have favourable implications on patient outcome and duration of hospital stay.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Atrial fibrillation (AF)
Intervention
First time CABG patients who develop atrial fibrillation in the post-operative period following discharge from intensive care will be randomly assigned to one of two groups. Group one will be administered oral amiodarone and group two will receive DC cardioversion in addition to oral amiodarone. Daily electrocardiogram (ECG) will document heart rhythm. A blinded independent researcher will interpret the ECG on the day of discharge.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Patient's cardiac rhythm at discharge
Secondary outcome measures
1. Duration between onset of atrial fibrillation and reversion to sinus rhythm
2. Duration of hospital stay
3. Patient's rhythm on outpatient follow-up at 6 weeks postoperatively
Overall trial start date
08/05/2003
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
400 first time CABG patients who develop atrial fibrillation in the post-operative period following discharge from intensive care will be randomly assigned to one of two groups.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
08/05/2003
Recruitment end date
01/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiac Surgery
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary