Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001425280
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
27/08/2018
Date last updated
27/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of early versus delayed elective electrical cardioversion
for recurrent episodes of persistent atrial fibrillation
Scientific title
A comparison of early versus delayed elective electrical cardioversion
for recurrent episodes of persistent atrial fibrillation
Secondary ID [1] 295872 0
Nil known
Universal Trial Number (UTN)
U1111-1219-2728
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 309337 0
Condition category
Condition code
Cardiovascular 308201 308201 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Emergency cardioversion (ED-CV) group: patients presenting to the Emergency Department for an 'early' cardioversion for AF recurrence. Observed for 12 months from cardioversion date.
Intervention code [1] 312205 0
Not applicable
Comparator / control treatment
Elective cardioversion (EL-CV) group: patients referred for elective outpatient cardioversion for AF recurrence - data to be collected from Royal Melbourne & Alfred Hospitals from 2/2014 - 8/2018. Observed fro 12 months from cardioversion date.
Control group
Historical

Outcomes
Primary outcome [1] 307169 0
Time to persistent AF recurrence (documented on ECG). To be collected from medical records, ECGs, Holters performed during follow-up period.
Timepoint [1] 307169 0
Within 12 months of cardioversion. To be collected from medical records, and clinically-indicated ECGs, Holters performed throughout the follow-up period.
Secondary outcome [1] 350965 0
AF duration prior to CV - directly collected from medical records.
Timepoint [1] 350965 0
Time from onset of AF to cardioversion (in days, as confirmed by ECG)
Secondary outcome [2] 350966 0
Changes in left atrial (LA) area (cm2) on echocardiography from baseline to follow-up
Timepoint [2] 350966 0
Prior to cardioversion to 12 month follow-up
Secondary outcome [3] 350967 0
Modified European Heart Rhythm Association (EHRA) score
Timepoint [3] 350967 0
12 months post cardioversion
Secondary outcome [4] 350968 0
Time to referral for AF ablation - directly collected from medical records.
Timepoint [4] 350968 0
Within first 12 months from cardioversion

Eligibility
Key inclusion criteria
Patients with persistent AF, as defined by a previous or current episode of AF lasting longer than 7 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Persistent AF with prior early re-initiation of AF within 1 month; (2) Paroxysmal AF, with a prior history of spontaneous reversion within 7 days or chemical reversion; (3) Atrial flutter as the only documented rhythm; (4) Permanent AF, where sinus rhythm was unable to be restored; (5) Asymptomatic or minimally symptomatic patients as they are frequently unsure of time of symptom onset; (6) Previous AF ablation.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Baseline characteristics and outcome measures will be summarized as mean ± standard deviation or median, where appropriate. The Shapiro-Wilk test will be performed to confirm normal distribution of data. The chi-square test will be used to compare categorical variables, and Wilcoxon rank-sum test or Student’s t-tests used for continuous variables. With respect to analysis of ‘time to AF recurrence’ and ‘time to referral for AF ablation’, these will be performed using time-to-event methods with outcomes in the two study groups to be compared with the use of hazard ratios and 95% confidence intervals using a Cox proportional-hazards regression model. Multiple linear regression analysis will be performed to determine independent clinical predictors of AF-free survival at follow-up. Duration of AF-free survival will be used as the continuous dependent variable.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/07/2018
Date of last participant enrolment
Anticipated
Actual
24/08/2018
Date of last data collection
Anticipated
Actual
24/08/2018
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11704 0
The Alfred - Prahran
Recruitment hospital [2] 11705 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 23785 0
3004 - Prahran
Recruitment postcode(s) [2] 23786 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 300469 0
Self funded/Unfunded
Name [1] 300469 0
Professor Jonathan Kalman
Country [1] 300469 0
Australia
Primary sponsor type
Individual
Name
Professor Jonathan Kalman
Address
Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052
Country
Australia
Secondary sponsor category [1] 299938 0
Individual
Name [1] 299938 0
Professor Peter Kistler
Address [1] 299938 0
Alfred Hospital, Commercial Rd, Prahran, VIC, Australia, 3181
Country [1] 299938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301271 0
Melbourne Health HREC
Ethics committee address [1] 301271 0
Ethics committee country [1] 301271 0
Australia
Date submitted for ethics approval [1] 301271 0
13/06/2018
Approval date [1] 301271 0
10/07/2018
Ethics approval number [1] 301271 0
QA2018073

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86438 0
Prof Jonathan Kalman
Address 86438 0
Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052
Country 86438 0
Australia
Phone 86438 0
+61 3 93428989
Fax 86438 0
Email 86438 0
[email protected]
Contact person for public queries
Name 86439 0
Alex Voskoboinik
Address 86439 0
Dept of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052
Country 86439 0
Australia
Phone 86439 0
+61 3 90762000
Fax 86439 0
Email 86439 0
[email protected]
Contact person for scientific queries
Name 86440 0
Alex Voskoboinik
Address 86440 0
Dept of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052
Country 86440 0
Australia
Phone 86440 0
+61 3 90762000
Fax 86440 0
Email 86440 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.