Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr W Dihmis

ORCID ID

Contact details

Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
+44 (0)151 228 1616

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes