Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001224819
Ethics application status
Approved
Date submitted
28/01/2012
Date registered
20/11/2012
Date last updated
15/02/2017
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
NA
Universal Trial Number (UTN)
U1111-1127-5110
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

Intervention/exposure
Study type
Interventional
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
Historical

Outcomes
Primary outcome [1] 286376 0
Change in AF cycle length, by measurement of cycle length on intracardiac electrogram.
Timepoint [1] 286376 0
Intraprocedural
Primary outcome [2] 286442 0
Change to atrial tachycardia, by assessment of intracardiac electrograms.
Timepoint [2] 286442 0
Intraprocedural
Primary outcome [3] 286443 0
Termination of AF, by assessment of intracardiac electrograms
Timepoint [3] 286443 0
Intraprocedural
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
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
Country [1] 284589 0
Australia
Funding source category [2] 286351 0
Self funded/Unfunded
Name [2] 286351 0
Royal Adelaide Hospital Department of Cardiac Electrophysiology
Country [2] 286351 0
Australia
Primary sponsor type
Hospital
Name
Prof Prash Sanders, Dr Anand Ganesan
Address
L5 McEwin Building
North Terrace
Adelaide SA 5000
Australia
Country
Australia
Secondary sponsor category [1] 285140 0
None
Name [1] 285140 0
Address [1] 285140 0
Country [1] 285140 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 286575 0
Approval date [1] 286575 0
09/07/2012
Ethics approval number [1] 286575 0
RAH 120623

Summary
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
TBA
Trial related presentations / publications
TBA
Public notes

Contacts
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
Australia
Phone 16939 0
+61-8-8222-2723
Fax 16939 0
+61-8-8222-2722
Email 16939 0
[email protected]
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
Australia
Phone 7867 0
+61-8-8222-2723
Fax 7867 0
+61-8-8222-2722
Email 7867 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.