Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001004459
Ethics application status
Approved
Date submitted
8/10/2024
Date registered
10/09/2025
Date last updated
10/09/2025
Date data sharing statement initially provided
10/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the cardiac electrical signals in patients with Atrial Fibrillation
Scientific title
Retrospective and Prospective Analysis of Intracardiac Electro-Anatomic Data in Patients with Atrial Fibrillation
Secondary ID [1] 312781 0
None
Universal Trial Number (UTN)
Trial acronym
The ICE-AF study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 334835 0
Condition category
Condition code
Cardiovascular 331394 331394 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will be conducted retrospectively and prospectively to examine the 3D electro-anatomic maps and intracardiac signals of participants who have undergone AF ablation at the Lyell McEwin Hospital.

A total of 400 electronic medical records will be accessed which includes both retrospective and prospective data. Electronic data will be collected to examine the 3D electro-anatomic maps and intracardiac signals of participants who have undergone AF ablation at the Lyell McEwin and Ashford Hospitals. A waiver of consent to collect retrospective data (5 years) for 200 patients is provided for this study (Central Adelaide Local Health Network Human Research Committee). Therefore, no patient contact or consent is required. Prospective data (n = 200) will be collected for five years from the start of the study (2024) until 2030 from participants who are booked for an AF ablation at the Lyell McEwin Hospital, Cardiology Department and Ashford Hospital. They will be informed about the study by one of the study investigators and required to provide Consent to collect data only. All participant data will be de-identified and given a unique study ID number.
Intervention code [1] 329311 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339140 0
Prevalence of epicardial septo-pulmonary bundle(SPB) mediated left atrial activation in patients undergoing AF ablation
Timepoint [1] 339140 0
This information will be collected from the ablation electroanatomic maps (for most patients one time point, for those who undergo redo ablation for clinical lesions, these will be additional timepoints). The ethics approval is for analysis of data of 200 patients retrospectively and 200 patients enrolled prospectively. Additional data will be collected from medical records for 24 months from baseline (after ablation).
Primary outcome [2] 339141 0
Electro-anatomic patterns of SPB mediated left atrial posterior wall activation
Timepoint [2] 339141 0
The electro-anatomic data will be collected at baseline, prospective data: immediately after initial AF ablation and at any redo procedures for 5 years from enrollment.
Primary outcome [3] 339685 0
Delineation of electrophysiological characteristics of near field and far field atrial signals
Timepoint [3] 339685 0
This will be assessed from the electro-anatomic maps of AF ablation, both the initial (baseline) study and also any subsequent redo procedures. The clinical data will be collected for both retrospective and prospective enrolled participants from medical records at baseline and till 24 months after last ablation.
Secondary outcome [1] 440893 0
AF recurrence outcome
Timepoint [1] 440893 0
12 months post ablation
Secondary outcome [2] 451664 0
AF recurrence outcome for Radiofrequency ablation vs Pulsed Field Ablation
Timepoint [2] 451664 0
12 months post ablation
Secondary outcome [3] 451665 0
Patterns of Gaps during Pulsed Field ablation.
Timepoint [3] 451665 0
Baseline AF ablation and at any redo procedures for 5 years from enrollment.

Eligibility
Key inclusion criteria
Inclusion Criteria
• 18 years and over.
• Participants who have undergone ablation for AF or atrial tachyarrhythmias at the Lyell McEwin Hospital and Ashford Hospital between 2019 and 2030.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• No ablation performed

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Summary statistics to provide a basic understanding of the data’s central tendencies and variability (i.e. means, medians, standard deviations, and distributions). This is foundational and will assist in the initial data exploration phase.
t-Tests / ANOVA/ Mann-Whitney U Test / Kruskal-Wallis Test: These tests will help compare the means of different groups (e.g. no gaps, gaps) to determine if there are statistically significant differences in key features like voltage, activation time, and spatial relationships.
Confusion matrix, ROC (receiver operating characteristic curve), AUC (area under the ROC curve), Balanced Accuracy, F1 Score: These metrics are critical for evaluating the performance of the machine learning model and help us understand the model’s sensitivity, specificity, and overall accuracy in detecting conduction gaps.

AF recurrence- The Kaplan-Meier product-limit method will used to estimate the time to recurrence and event-free survival curves after the last ablation procedure. Requirement for a repeat procedure will be considered an endpoint. Predictors of recurrent AF will be
assessed in Cox regression models after verifying proportionality assumptions. Candidate variables with p < 0.1 in univariate analyses will be considered in multivariate stepwise regression models. Two tailed p values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/05/2025
Date of last participant enrolment
Anticipated
1/06/2028
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
400
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26964 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 28400 0
Ashford Community Hospital - Ashford
Recruitment postcode(s) [1] 43038 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 44624 0
5035 - Ashford

Funding & Sponsors
Funding source category [1] 317212 0
University
Name [1] 317212 0
The University of Adelaide
Country [1] 317212 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319481 0
None
Name [1] 319481 0
Address [1] 319481 0
Country [1] 319481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315950 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315950 0
Ethics committee country [1] 315950 0
Australia
Date submitted for ethics approval [1] 315950 0
03/06/2024
Approval date [1] 315950 0
29/07/2024
Ethics approval number [1] 315950 0
CALHN Reference Number: 19660

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

Contacts
Principal investigator
Name 136322 0
A/Prof Rajiv Mahajan
Address 136322 0
University Precinct, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, South Australia 5112
Country 136322 0
Australia
Phone 136322 0
+61 416 701 492
Fax 136322 0
Email 136322 0
[email protected]
Contact person for public queries
Name 136323 0
Rajiv Mahajan
Address 136323 0
University Precinct, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, South Australia 5112
Country 136323 0
Australia
Phone 136323 0
+61 416 701 492
Fax 136323 0
Email 136323 0
[email protected]
Contact person for scientific queries
Name 136324 0
Rajiv Mahajan
Address 136324 0
University Precinct, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, South Australia 5112
Country 136324 0
Australia
Phone 136324 0
+61 416 701 492
Fax 136324 0
Email 136324 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This data will be de-identified and reported as aggregate.



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.