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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing exercise capacity, inflammation and endothelial function following cardioversion between asymptomatic and symptomatic patients with atrial fibrillation
Scientific title
Changes in exercise capacity, inflammation and endothelial function following cardioversion in asymptomatic versus symptomatic persistent atrial fibrillation
Secondary ID [1] 284961 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 292454 0
Condition category
Condition code
Cardiovascular 292770 292770 0 0
Other cardiovascular diseases

Study type
Description of intervention(s) / exposure
Direct electrical cardioversion. The cardioversion will be performed under sedation. Remote patches will be attached in Anterior-posterior or anterior-lateral position and 200 Joule synchronized shock will be delivered. A maximum of three shocks will be delivered to restore sinus rhythm. Cardioversion will be performed on a single occasion, lasting approximately 30 minutes.
Intervention code [1] 289790 0
Treatment: Other
Intervention code [2] 289867 0
Treatment: Devices
Comparator / control treatment
Symptomatic AF patients
Control group

Primary outcome [1] 292620 0
Exercise capacity, defined using peak oxygen consumption
Timepoint [1] 292620 0
12 weeks post cardioversion
Secondary outcome [1] 309348 0
Endothelial Function, assessed by reactive hyperemia and serum assay.
Timepoint [1] 309348 0
12 weeks
Secondary outcome [2] 309349 0
Inflammation assessed by serum assay
Timepoint [2] 309349 0
12 weeks

Key inclusion criteria
Persistent AF, defined as an episode of AF lasting longer than 7 days or lasts <7 days and requires direct cardioversion.
Rate controlled during AF with resting ventricular rate less than 110bpm.
Able and willing to provide written informed consent to participate.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients contraindicated for exercise testing according to American Heart Association guidelines.
Paroxysmal (AF duration <7 days) or Permanent AF (AF duration >1 year).
Decompensated heart failure
Unstable angina.
Hemodynamic instability defined as systolic blood pressure less than 90mmHg.
Previous AF ablation
Pregnancy or suspected pregnancy

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis
To examine the predictors of change in exercise capacity following cardioversion, we will use a multivariable mixed-effects model with the change in exercise capacity (VO2max) as the dependent variable. Analysis of variance (ANOVA) for repeated measures will be used to assess the change of haematological, morphological and QoL parameters following cardioversion. A P value <0.05 will be considered significant.

Using the mean VO2max value of 20.7+/- 6.3 ml/kg/min reported in persistent AF (Fiala et al., 2013) and a 50% attrition rate accounting for those not remaining in sinus rhythm, a recruitment target of 35 patients per group will give 80% power to detect a 3.5 ml/kg/min change in VO2max.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 2714 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 289582 0
Name [1] 289582 0
University of Adelaide
Address [1] 289582 0
North Terrace
SA 5005
Country [1] 289582 0
Primary sponsor type
Centre for Heart Rhythm Disorders
Centre for Heart Rhythm Disorders
Level 5
Royal Adelaide Hospital
North Terrace
SA 5000
Secondary sponsor category [1] 288267 0
Name [1] 288267 0
School of Medical Sciences
Address [1] 288267 0
School of Medical Sciences
Level 4 Medical School South
Frome Road
SA 5005
Country [1] 288267 0

Ethics approval
Ethics application status
Ethics committee name [1] 291319 0
Royal Adelaide Hospital
Ethics committee address [1] 291319 0
Level 3, IMVS Building
Royal Adelaide Hospital
SA 5000
Ethics committee country [1] 291319 0
Date submitted for ethics approval [1] 291319 0
Approval date [1] 291319 0
Ethics approval number [1] 291319 0

Brief summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1-2% of the population. Many patients remain asymptomatic, likely leading to an underestimation of the true prevalence of AF. Of particular importance is the similar risk of stroke and adverse health outcomes in the asymptomatic cohort. Catheter ablation has emerged as an effective treatment for symptomatic AF. However, the risk to benefit ratio of an ablation procedure in asymptomatic AF is less established.

(i) Examine whether the restoration of sinus rhythm by cardioversion in asymptomatic patients improves exercise capacity to a similar degree as patients with symptomatic AF.
(ii) Compare baseline and post-exercise parameters of the prothrombotic state between symptomatic and asymptomatic patients both before after cardioversion

(1) We hypothesize that exercise capacity will be similarly impaired in symptomatic and asymptomatic patients and improve following restoration of sinus rhythm following cardioversion.
(2) We further hypothesise that:
a. acute exercise will elevate the prothrombotic state in both symptomatic and asymptomatic patients and;
b. inflammation and endothelial dysfunction will be observed in both patient cohorts and similarly improved following the return of sinus rhythm.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 49870 0
Prof Prashanthan Sanders
Address 49870 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
SA 5000
Country 49870 0
Phone 49870 0
Fax 49870 0
Email 49870 0
Contact person for public queries
Name 49871 0
Dr Adrian Elliott
Address 49871 0
School of Medical Sciences, University of Adelaide
Med School South, Frome Road
SA 5005
Country 49871 0
Phone 49871 0
Fax 49871 0
Email 49871 0
Contact person for scientific queries
Name 49872 0
Dr Rajiv Mahajan
Address 49872 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
SA 5000
Country 49872 0
Phone 49872 0
Fax 49872 0
Email 49872 0

No information has been provided regarding IPD availability
Summary results
No Results