Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001200370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
20/08/2026
Date registered
Help: Date registered
28/09/2026
Date last updated
Help: Date last updated
28/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of topology-Informed Pulsed-Field Ablation (PFA) in Atrial fibrillation Patients using real-time cardiac signal analysis (TOPOLOOGY PFA)
Scientific title
A randomised trial of topology-Informed Pulsed-Field Ablation (PFA) in Atrial fibrillation Patients using real-time cardiac signal analysis (TOPOLOOGY PFA)
Additional trial identifiers [1] 318320 0
Nil
Universal Trial Number (UTN)
U1111-1345-7009
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Atrial fibrillation 343295 0
Condition category
Condition code
Cardiovascular 339413 339413 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention group will undergo pulmonary vein isolation in addition to ablation of the top 5 regions of decreased spatiotemporal intermittency as measured by low multifractal C2. These regions will be identified in real time using software and analysis algorithms that have been developed by our research group. The atria will be mapped using a high density catheters to collect data on the geometry and local electrograms (with electrograms being interrogated in real time to determine areas of interest for ablation – up to 5 additional sites) within the atria prior to ablation and then remapped following ablation to investigate local signal change. The mapping duration will be 30-60s at each site. Typical catheters used will be standard to the procedure such as the HD grid catheter which is a standard catheter used in AF ablation. Analysis of the outputs will be performed by the research team consisting of a technical operator supervising the computational analysis, which will be interpreted and applied by the electrophysiologist investigators performing the ablation procedure. All staff are trained and familiar with multifractal analyses of electrogram signals in atrial fibrillation.
Intervention code [1] 335131 0
Treatment: Other
Description of the comparator or control
Participants undergo standard wide-antral pulmonary vein isolation using pulsed-field ablation only by an electrophysiologist, with no additional mapping or ablation of STI (spatio-temporally intermittent) regions. The anticipated duration is 20 minutes per participant. PVI is performed as per standard protocol using an electroanatomic mapping system.
Control group
Active

Outcomes
Primary outcome [1] 346620 0
Local change in vector organization index adjacent to ablation lesions (composite of vector correlation, spatial coherence)
Timepoint [1] 346620 0
Intraprocedural, at the time of ablation; can also be evaluated from recorded data post ablation.
Primary outcome [2] 346621 0
Increase in global organisation of atrial fibrillation wavefronts as measured by increased global c2 values (indicating a transition from persistent fibrillatory state to increased intermittency)
Timepoint [2] 346621 0
Intraprocedural at the time of ablation
Primary outcome [3] 346726 0
Change in AF Cycle Length
Timepoint [3] 346726 0
Intraprocedural - by comparison of pre-ablation AFCL to post ablation AFCL
Secondary outcome [1] 466775 0
Atrial tachyarrhythmia/AF recurrence post ablation as a composite secondary outcome
Timepoint [1] 466775 0
6 months and, and 12 months post ablation

Eligibility
Key inclusion criteria
• Adults aged 18 years and above
• Scheduled to undergo de novo pulmonary vein isolation procedure
• Patients with persistent atrial fibrillation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Key exclusion criteria include prior AF ablation (which would confound assessment of de novo ablation-induced topological changes), contraindications to anticoagulation or general anaesthesia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer generated sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
(1) computer-generated random sequenc
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary purpose of this pilot is feasibility and effect-size estimation, it is not hypothesis testing. This is standard for pilot studies and it is not expected to detect differences in clinical outcomes.
With regards to the precision of mechanistic primary endpoints, with n=20/arm we expect to have a ~ 85% power to detect a between group difference of 25ms (clinically relevant threshold for “slowing” of the atrial fibrillation cycle length)
Findings in this study are meant to be hypothesis generating only and require confirmation in an adequately powered RCT.
We expect that recruitment of n=40 participants will be achievable at our centre within 12-18 months,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2026
Actual
Date of last participant enrolment
Anticipated
31/08/2028
Actual
Date of last data collection
Anticipated
31/08/2029
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 30057 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [2] 30058 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 46451 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 322764 0
Government body
Name [1] 322764 0
Southern Adelaide Local Health Network
Country [1] 322764 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 325685 0
None
Name [1] 325685 0
Address [1] 325685 0
Country [1] 325685 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321200 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 321200 0
Ethics committee country [1] 321200 0
Australia
Date submitted for ethics approval [1] 321200 0
Approval date [1] 321200 0
10/03/2026
Ethics approval number [1] 321200 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152998 0
Prof Anand Ganesan
Address 152998 0
Department of Cardiology, 1 Fiinders Drive, Flinders Medical Centre, Bedford Park SA 5042
Country 152998 0
Australia
Phone 152998 0
+61 8 8204 5619
Fax 152998 0
Email 152998 0
[email protected]
Contact person for public queries
Name 152999 0
Anand Ganesan
Address 152999 0
Department of Cardiology, 1 Fiinders Drive, Flinders Medical Centre, Bedford Park SA 5042
Country 152999 0
Australia
Phone 152999 0
+61 8 8204 5619
Fax 152999 0
Email 152999 0
[email protected]
Contact person for scientific queries
Name 153000 0
Anand Ganesan
Address 153000 0
Department of Cardiology, 1 Fiinders Drive, Flinders Medical Centre, Bedford Park SA 5042
Country 153000 0
Australia
Phone 153000 0
+61 8 8204 5619
Fax 153000 0
Email 153000 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not approved by HREC



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] HREC approval TOPOLOGY PFA.pdf
Other  [email protected] SSA approval SSA approval TOPOLOGY PFA.pdf


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.