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
Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052
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
As an emerging epidemic of cardiovascular disease, increasing numbers of patients are utilizing electrical cardioversion (CV) for treatment of symptomatic persistent atrial fibrillation (PeAF). The timing of CV following AF recurrence is dictated by a combination of factors, including patient symptoms, physician preference and resource availability. In addition to adverse effects on quality of life from prolonged AF duration, progressive adverse electrical and structural changes occur in the atria at different time points following arrhythmia onset . The clinical implications of delayed CV for intermittent PeAF are not well categorized, although some studies suggest these patients are at higher risk of AF recurrence . Due to barriers to accessing early elective cardioversion, including time taken to see a family physician, obtain specialist referral and wait for a scheduled CV, we adopted a policy of instructing patients to present directly to the Emergency department for early cardioversion.

We sought to retrospectively compare a strategy of early ‘Emergency’ CV versus delayed ‘Elective’ CV for treatment of intermittent PeAF. We hypothesized that benefits of early CV may extend beyond symptoms, including prevention of adverse remodelling, reduction in recurrence risk and potentially lower utilization of AF ablation.

In this observational retrospective cohort study, we plan to evaluate 150 patients presenting with symptomatic PeAF presenting to two centers in metropolitan Melbourne between 2/2014 – 7/2017. All included patients have a history of persistent AF, as defined by a previous or current episode of AF lasting longer than 7 days. We seek to compare two patient groups – those treated with Emergency vs Elective cardioversion strategies and included 75 consecutive patients from each group. Follow-up is over 12 months.

Follow up for 12 months following cardioversion includes 12-lead ECG at onset of symptoms and during outpatient review at 3 months post discharge and 6 – 12 monthly thereafter. Referral for AF ablation is routinely initiated for symptomatic AF despite 1 – 2 antiarrhythmic agents.

The primary endpoint is time to persistent AF recurrence. Secondary endpoints include AF duration prior to CV, changes in left atrial (LA) size on echocardiography from baseline to follow-up, modified European Heart Rhythm Association (EHRA) score at 12 months and time to referral for AF ablation.

Medical records, including specialist and family physician visits, emergency and inpatient discharge summaries and echocardiographic data will be reviewed for recurrences, subsequent referrals for AF ablation and other endpoints.
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
Dr 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
Dr 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

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