ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

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]

Time to persistent AF recurrence (documented on ECG). To be collected from medical records, ECGs, Holters performed during follow-up period.

Timepoint [1]

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]

AF duration prior to CV - directly collected from medical records.

Timepoint [1]

Time from onset of AF to cardioversion (in days, as confirmed by ECG)

Secondary outcome [2]

Changes in left atrial (LA) area (cm2) on echocardiography from baseline to follow-up

Timepoint [2]

Prior to cardioversion to 12 month follow-up

Secondary outcome [3]

Modified European Heart Rhythm Association (EHRA) score

Timepoint [3]

12 months post cardioversion

Secondary outcome [4]

Time to referral for AF ablation - directly collected from medical records.

Timepoint [4]

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?

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]

The Alfred - Prahran

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3004 - Prahran

Recruitment postcode(s) [2]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Professor Jonathan Kalman

Address [1]

Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052

Country [1]

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]

Individual

Name [1]

Professor Peter Kistler

Address [1]

Alfred Hospital, Commercial Rd, Prahran, VIC, Australia, 3181

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health HREC

Ethics committee address [1]

Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/06/2018

Approval date [1]

10/07/2018

Ethics approval number [1]

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

Prof Jonathan Kalman

Address

Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052

Country

Australia

Phone

+61 3 93428989

Fax

jon.kalman@mh.org.au

Contact person for public queries

Name

Alex Voskoboinik

Address

Dept of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052

Country

Australia

Phone

+61 3 90762000

Fax

a.voskoboinik@alfred.org.au

Contact person for scientific queries

Name

Alex Voskoboinik

Address

Dept of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, VIC, Australia, 3052

Country

Australia

Phone

+61 3 90762000

Fax

a.voskoboinik@alfred.org.au

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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