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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
A new way of selecting atrial electrograms for ablation
Scientific title
In patients with atrial fibrillation undergoing catheter ablation, is ablation guided by novel signal processing algorithms effective in terms of atrial fibrillation (AF) cycle length, atrial tachycardia and procedural termination of AF
Secondary ID [1] 279811 0
Universal Trial Number (UTN)
Trial acronym
No acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 285693 0
Condition category
Condition code
Cardiovascular 285879 285879 0 0
Other cardiovascular diseases

Study type
Description of intervention(s) / exposure
Pulmonary vein isolation(PVI)+/- linear left atrial compartmental ablation with roof line +/- dominant frequency ablation targeting the 5 mapped sites using novel computation algorithms, including Shannon entropy. Linear compartmental ablation will be determined on an individualised basis by operator. Allocation to dominant frequency ablation will be randomised.Mitral isthmus line will be permitted but discouraged. Atrial tachcyardia ablation will be permitted. Endpoint of ablation is PVI +/- termination of AF during the procedure. The procedure is individualised and the duration can vary widely depending on patient anatomy and technical factors.
Intervention code [1] 284133 0
Treatment: Other
Comparator / control treatment
The trial is a single arm prospective pilot study. Comparison may be made with historical controls from our hospital database 2006-2012.
Control group

Primary outcome [1] 286376 0
Change in AF cycle length, by measurement of cycle length on intracardiac electrogram.
Timepoint [1] 286376 0
Primary outcome [2] 286442 0
Change to atrial tachycardia, by assessment of intracardiac electrograms.
Timepoint [2] 286442 0
Primary outcome [3] 286443 0
Termination of AF, by assessment of intracardiac electrograms
Timepoint [3] 286443 0
Secondary outcome [1] 295712 0
symptomatic AF/atrial tachyarrhythmia, by clinical review and Holter-monitor.
Timepoint [1] 295712 0
6-week, 3-months, 6-months, 9-months, 12-months.
Secondary outcome [2] 295899 0
Need for anti-arrhythmic drugs. This will be assessed at clinical follow-up by treating physician by chart review.
Timepoint [2] 295899 0
6-week, 3-months, 6-months, 9-months, 12-months.
Secondary outcome [3] 295900 0
requirement for hospitalisation. This will be assessed at clinical follow-up and patient hospital record retrieval.
Timepoint [3] 295900 0
6-week, 3-months, 6-months, 9-months, 12-months.
Secondary outcome [4] 295901 0
need for repeat procedures. This will be assessed by chart review.
Timepoint [4] 295901 0
6-week, 3-months, 6-months, 9-months, 12-months.

Key inclusion criteria
The study population will be patients undergoing curative catheter ablation for atrial fibrillation defined according to the HRS/ACC consensus statement at Royal Adelaide Hospital. The planned recruitment is 20patients over a study period of 18 months.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
The following exclusion criteria will apply: (i) age <18 years; (ii) pregnancy (iii) left atrial appendage thrombus on transoesophageal echocardiography (iv)previous AF ablation.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled through clinical screening prior to AF ablation. The study will be open-label in terms of allocation concealment, as it is not practical to conceal ablation strategy from the operator. There is a single arm, so treatment allocation does not apply.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 284589 0
Self funded/Unfunded
Name [1] 284589 0
Royal Adelaide Hospital Department of Cardiac Electrophysiology
Address [1] 284589 0
L5 McEwin Building
North Terrace
Adelaide SA 5000
Country [1] 284589 0
Funding source category [2] 286351 0
Self funded/Unfunded
Name [2] 286351 0
Royal Adelaide Hospital Department of Cardiac Electrophysiology
Address [2] 286351 0
L5 McEwin Building
North Terrace
Adelaide SA 5000
Country [2] 286351 0
Primary sponsor type
Prof Prash Sanders, Dr Anand Ganesan
L5 McEwin Building
North Terrace
Adelaide SA 5000
Secondary sponsor category [1] 285140 0
Name [1] 285140 0
Address [1] 285140 0
Country [1] 285140 0

Ethics approval
Ethics application status
Ethics committee name [1] 286575 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 286575 0
IMVS Building Level 3
North Terrace
Adelaide SA 5000
Ethics committee country [1] 286575 0
Date submitted for ethics approval [1] 286575 0
Approval date [1] 286575 0
Ethics approval number [1] 286575 0
RAH 120623

Brief summary
Atrial fibrillation (AF) is a disorganised abnormal heart rhythm which causes the heart to beat in an irregular fashion. Current curative ablation methods are based on targeted circles of burns around the openings of the pulmonary veins which are connected to the left atrium (or “top chamber”) of the heart. We call this part of the procedure pulmonary vein isolation.
In some patients, pulmonary vein isolation alone is not enough to cure their AF. In this case, the conventional strategy is to apply additional burns in special sites in the atrium with irregular local electrical signals. These areas are called complex fractionated atrial electrogram sites (or CFAE, pronounced like ‘café’). We believe, however, that other areas that may be selected with novel computational algorithms may be important to sustaining AF in many patients. The aim of this project is to examine whether burns targeting these sites in the atrium will improve control of AF, and improve cure rates for ablation.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33692 0
Address 33692 0
Country 33692 0
Phone 33692 0
Fax 33692 0
Email 33692 0
Contact person for public queries
Name 16939 0
Anand Ganesan
Address 16939 0
Centre For Heart Rhythm Disorders
L5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 16939 0
Phone 16939 0
Fax 16939 0
Email 16939 0
Contact person for scientific queries
Name 7867 0
Anand Ganesan
Address 7867 0
Centre For Heart Rhythm Disorders
L5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 7867 0
Phone 7867 0
Fax 7867 0
Email 7867 0

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