Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001166369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/08/2026
Date registered
Help: Date registered
18/09/2026
Date last updated
Help: Date last updated
18/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Focal Finder Pacing Validation Study: Validation of a Geodesic Focal Source Localisation Algorithm Using Systematic Pacing
Scientific title
Geodesic Focal Source Localisation Algorithm Using Systematic Pacing in Adults undergoing cardiac electrophysiology (EP) study
Additional trial identifiers [1] 318187 0
Nil known
Universal Trial Number (UTN)
U1111-1345-3959
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Focal arrhythmia 343245 0
Condition category
Condition code
Cardiovascular 339354 339354 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study involves systematic atrial pacing and electroanatomic mapping performed as an adjunct to clinically indicated electrophysiology (EP) procedures. After completion of the standard clinical EP procedure and prior to catheter removal, the research component is undertaken. This consists of:

1. Systematic pacing of predefined atrial sites in all patients [High Crista Terminalis,Low Crista Terminalis, Tricuspid Annulus , Septum, AV Node, Coronary Sinus Ostium, Superior Tricuspid Annulus, Right Atrial Appendage] using standard intracardiac catheters already in situ [HD Advisor, Ablation catheter, Coronary Sinus Catheter).
2. Recording of intracardiac electrograms and electroanatomic data during each pacing sequence.
3. Analysis of the recorded activation signals using the investigational Focal Finder software algorithm, which applies a geodesic focal source localisation approach to estimate the pacing origin. This can be performed offline after the procedure OR live during the procedure on a separate computer not used in the clinical procedure. If used live during the procedure, this is only used for data acquisition workflow simplification and does not affect the clinical procedure.

Because the true pacing location is known, algorithm predictions can be compared against ground truth, allowing validation of localisation accuracy.

Additional notes:
1. Focal Finder will preferentially be performed live during electrophysiology studies. The protocol allows for the acccuracy of the algorithm to be evaluated on recorded protocol data for a run in period of 10 patients at the start of the study.
2. Electrogram durations in are typically 10-20ms with standard filter settings
3. Total duration of the mapping protocol is anticipated to take 20 minutes for the pacing simulation study.
Intervention code [1] 335082 0
Diagnosis / Prognosis
Description of the comparator or control
Focal Finder algorithm estimation of 3D location of source site is compared to the actual 3D location of paced source. The comparator is the known pacing site (ground truth), against which the Focal Finder algorithm's predicted localisation is assessed. Each pacing site serves as its own reference. The comparison is made via geodesic distance from of site predicted by the algorithm to the true site.
Control group
Active

Outcomes
Primary outcome [1] 346561 0
To quantify the spatial localisation accuracy of the Focal Finder algorithm in the human atrium using systematic pacing from at least 10 distributed atrial sites, with 3, 5, and 7 sparse (local activation time) LAT samples per site.
Timepoint [1] 346561 0
Intraoperative
Secondary outcome [1] 466384 0
1. To determine the minimum number of local activation time (LAT) samples required to achieve less than 5 mm mean localisation error.
Timepoint [1] 466384 0
Intraprocedural/offline analysis
Secondary outcome [2] 466385 0
2. To characterise localisation accuracy across anatomical atrial locations (High Crista Terminalis, Low Crista, Terminalis, Tricuspid Annulus, Septum, AV Node, Coronary Sinus Ostium, Superior Tricuspid Annulus, Right Atrial Appendage). This will be assessed as a composite outcome
Timepoint [2] 466385 0
Intraprocedural or via offline analysis.
Secondary outcome [3] 466386 0
3. To evaluate algorithm robustness to LAT measurement noise and anatomical mesh quality. This will be assessed as a composite outcome
Timepoint [3] 466386 0
Intraprocedural/offline analysis
Secondary outcome [4] 466387 0
4. To measure algorithm computation time per LAT update to confirm real-time deployment feasibility.
Timepoint [4] 466387 0
Intraprocedural/offline analysis

Eligibility
Key inclusion criteria
• Age 18 years or older.
• Undergoing a clinically indicated EP procedure (including but not limited to: supraventricular tachycardia ablation, atrial flutter ablation, atrial fibrillation ablation, ventricular ectopy ablation, or diagnostic EP study).
• Sinus rhythm present or achievable during the research component of the procedure.
• Willing and able to provide written informed consent.
• Electroanatomic mapping with Abbott EnSiteX planned as part of or amendable to the clinical procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Spontaneous sustained atrial tachycardia or atrial flutter during the research component that cannot be terminated.
• Haemodynamic instability precluding research pacing protocol.
• Inability to obtain an adequate electroanatomic shell of the atrium (either right or left, as applicable).
• Pregnant or breastfeeding women.
• Unable to provide informed consent (e.g., language barrier without interpreter, cognitive impairment).
• Requirement for emergency intervention precluding research activities.

Study design
Purpose of the study
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary purpose of this validation study is to quantify algorithm performance rather than to test a statistical hypothesis. A sample of 30 participants, each providing at least 30 pacing sites, yields at least 900 pacing observations for analysis. This sample size is consistent with published validation studies of electrophysiological mapping algorithms and provides sufficient data to:
• Estimate the mean localisation error with a 95% confidence interval width of approximately 1 mm (assuming a standard deviation of 4 mm from computational validation data, and a minimum of 900 observations).
• Detect a clinically meaningful difference of 2 mm in mean localisation error between 3-sample and 7-sample conditions with greater than 90% power.
• Allow stratified sub-analyses by atrial region and anatomical mesh quality.
If fewer than 30 pacing sites per participant are achievable (e.g., due to catheter access limitations), additional participants may be enrolled with a target of at least 900 total pacing observations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2026
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29996 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 29997 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [3] 29998 0
Ashford Community Hospital - Ashford
Recruitment postcode(s) [1] 46394 0
5042 - Bedford Park
Recruitment postcode(s) [2] 46395 0
5035 - Ashford

Funding & Sponsors
Funding source category [1] 322753 0
Hospital
Name [1] 322753 0
Flinders Medical Centre
Country [1] 322753 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network (Flinders Medical Centre)
Address
Country
Australia
Secondary sponsor category [1] 325675 0
University
Name [1] 325675 0
Flinders University
Address [1] 325675 0
Country [1] 325675 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321191 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 321191 0
Ethics committee country [1] 321191 0
Australia
Date submitted for ethics approval [1] 321191 0
15/04/2026
Approval date [1] 321191 0
27/07/2026
Ethics approval number [1] 321191 0

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

Contacts
Principal investigator
Name 152962 0
Prof Anand Narayan Ganesan
Address 152962 0
Flinders Private Hospital, Ste 606, Level 6/1 Flinders Dr, Bedford Park SA 5042
Country 152962 0
Australia
Phone 152962 0
+61 8 8204 5619
Fax 152962 0
Email 152962 0
[email protected]
Contact person for public queries
Name 152963 0
Anand Narayan Ganesan
Address 152963 0
Flinders Private Hospital, Ste 606, Level 6/1 Flinders Dr, Bedford Park SA 5042
Country 152963 0
Australia
Phone 152963 0
+61 8 8204 5619
Fax 152963 0
Email 152963 0
[email protected]
Contact person for scientific queries
Name 152964 0
Anand Narayan Ganesan
Address 152964 0
Flinders Private Hospital, Ste 606, Level 6/1 Flinders Dr, Bedford Park SA 5042
Country 152964 0
Australia
Phone 152964 0
+61 8 8204 5619
Fax 152964 0
Email 152964 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethics has not approved sharing of individual study data



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.