Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001165370
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
PRospective EValuation of Artificial InteLligence-Enabled ECG for Predicting the Spontaneous Cardioversion of Atrial Fibrillation in Emergency Department AF Patients: PREVAIL – AF
Scientific title
PRospective EValuation of Artificial InteLligence-Enabled ECG for Predicting the Spontaneous Cardioversion of Atrial Fibrillation in Emergency Department AF Patients: PREVAIL – AF
Additional trial identifiers [1] 318259 0
Nil
Universal Trial Number (UTN)
U1111-1345-3945
Trial acronym
PREVAIL-AF
Related trial records

Health condition
Health condition(s) studied:
Atrial Fibrilation 343244 0
Condition category
Condition code
Cardiovascular 339353 339353 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
AI-ECG DECISION-SUPPORT TOOL (Intervention Arm): An artificial intelligence-enabled electrocardiogram (AI-ECG) tool — previously trained on ECG data from the REVERT-AF study — is applied to the presenting 12-lead ECG of patients with primary atrial fibrillation (AF) in the emergency department (ED). The tool analyses the ECG together with the patient's age and sex to produce a binary prediction: • "SCV predicted" — patient is likely to spontaneously cardiovert (return to sinus rhythm without intervention) • "Persistent AF predicted" — patient is unlikely to cardiovert without active treatment Patients predicted to undergo spontaneous cardioversion (SCV) are managed under a structured "wait-and-see" discharge protocol: — Heart rate control with standardised medical therapy— Anticoagulation per Australian AF guidelines (stroke risk stratification) — Discharge home from the ED, with discharged patients provided with AliveCor Kardia devices by hospital team to document rhythm status during discharged period — Follow-up cardiology appointment within 7 days at a an outpatient AF clinic Patients predicted to remain in persistent AF receive standard hospital care as determined by the treating clinician. The AI-ECG tool is run by authorised research team members who manually export ECG files from the hospital ECG system to a secure server. The tool then analyses the file and returns the prediction result. Duration of intervention: The AI-ECG tool is applied at a single time point in the ED (at enrolment). Follow-up continues for 12 months post-enrolment.
Intervention code [1] 335081 0
Early detection / Screening
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346559 0
PRIMARY OUTCOME 1: Feasibility outcome — Rate of successful enrolment and protocol adherence, defined as the composite proportion of eligible ED patients with primary AF who consent to participate and complete the AI-ECG assessment and structured discharge or admission protocol as per study procedures. Timepoint: During the ED presentation (Day 0 / enrolment visit)
Timepoint [1] 346559 0
During ED visit
Primary outcome [2] 346560 0
PRIMARY OUTCOME 2: Accuracy of the AI-ECG tool — Proportion of patients predicted to undergo spontaneous cardioversion (SCV) by the AI-ECG tool who actually achieve sinus rhythm within 48 hours of ED presentation (confirmed by ECG or cardiac monitoring). Timepoint: At 48 hours after ED presentation
Timepoint [2] 346560 0
Data collected at 48 hours after ED presentation will be assessed during the first clinic visit (anticipated to be within 7 days post ED visit)
Secondary outcome [1] 466381 0
SECONDARY OUTCOME 1: Rate of spontaneous cardioversion — Proportion of AI-ECG SCV-predicted patients who revert to sinus rhythm without pharmacological or electrical cardioversion during the index ED visit.
Timepoint [1] 466381 0
Patients are instructed to take x4 or more AliveCor traces per day; Up to first clinic visit (anticipated to be within 7 days post ED visit)
Secondary outcome [2] 466382 0
SECONDARY OUTCOME 2: Hospital admission rate — Proportion of AI-ECG SCV-predicted patients who are discharged directly from the ED versus admitted to hospital.
Timepoint [2] 466382 0
At ED discharge or admission day 0
Secondary outcome [3] 466383 0
SECONDARY OUTCOME 3: Length of stay — Time from ED presentation to ED discharge or hospital admission for participants.
Timepoint [3] 466383 0
Timepoint: At ED Discharge

Eligibility
Key inclusion criteria
1. Age 18 years or older 2. Presenting to the Flinders Medical Centre Emergency Department (or affiliated SALHN ED site) 3. Primary presenting complaint of atrial fibrillation (AF) confirmed on 12-lead ECG 4. AF episode duration unknown or estimated at less than 48 hours (first-detected or paroxysmal AF with uncertain onset) 5. Haemodynamically stable (no requirement for immediate emergency cardioversion) 6. Able to provide written informed consent. 7. Able to attend a follow-up cardiology appointment within 7 days of ED discharge 8. Willing and able to comply with all study procedures and follow-up requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Haemodynamically unstable AF requiring immediate electrical cardioversion 2. AF duration clearly greater than 48 hours 3. Permanent AF (known not to revert to sinus rhythm) 4. Prior catheter ablation for AF 5. Implanted cardiac device (pacemaker or implantable cardioverter-defibrillator [ICD]) that may interfere with ECG analysis 6. Unable to provide informed consent (e.g., significant cognitive impairment, acute delirium, or altered consciousness at time of presentation) 7. Unable to communicate in English (no interpreter available within the timeframe required for ED disposition decision) 8. Pregnant women 9. Children and young people under 18 years 10. Patients whose treating clinician determines they require immediate admission regardless of AF rhythm (e.g., for another acute medical condition)

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
Safety/efficacy
Statistical methods / analysis
This pilot feasibility study is not powered for formal hypothesis testing. Statistical analysis will be primarily descriptive. Descriptive statistics: Continuous variables will be summarised as means ± standard deviations or medians with interquartile ranges, as appropriate. Categorical variables will be reported as frequencies and proportions. Feasibility outcomes: Enrolment rate and protocol adherence rate will be reported as proportions with 95% confidence intervals. AI-ECG model performance: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI-ECG tool for predicting spontaneous cardioversion will be calculated using 2×2 contingency tables, with confirmed cardioversion status at 48 hours as the reference standard. Clinical outcomes (secondary): Rate of spontaneous cardioversion, hospital admission rate, length of stay, patient satisfaction scores, and MACE rates will be described with appropriate summary statistics and 95% confidence intervals. All analyses will be performed using appropriate statistical software (e.g., R or SPSS). No interim analysis is planned for this pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2026
Actual
Date of last participant enrolment
Anticipated
31/01/2028
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29994 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 29995 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 46392 0
5042 - Bedford Park
Recruitment postcode(s) [2] 46393 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 322751 0
Government body
Name [1] 322751 0
Southern Adelaide Local Health Network
Country [1] 322751 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network (Flinders Medical Centre)
Address
Country
Australia
Secondary sponsor category [1] 325674 0
None
Name [1] 325674 0
Address [1] 325674 0
Country [1] 325674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321190 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 321190 0
Ethics committee country [1] 321190 0
Australia
Date submitted for ethics approval [1] 321190 0
17/11/2025
Approval date [1] 321190 0
28/11/2025
Ethics approval number [1] 321190 0
HRE00226

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

Contacts
Principal investigator
Name 152958 0
Prof Anand Narayan Ganesan
Address 152958 0
Department of Cardiology, 1 Flinders Drive, Flinders Medical Centre, Bedford Park SA 5042
Country 152958 0
Australia
Phone 152958 0
+61 8 8204 5619
Fax 152958 0
Email 152958 0
[email protected]
Contact person for public queries
Name 152959 0
Anand Narayan Ganesan
Address 152959 0
Department of Cardiology, 1 Flinders Drive, Flinders Medical Centre, Bedford Park SA 5042
Country 152959 0
Australia
Phone 152959 0
+61 8 8204 5619
Fax 152959 0
Email 152959 0
[email protected]
Contact person for scientific queries
Name 152960 0
Anand Narayan Ganesan
Address 152960 0
Department of Cardiology, 1 Flinders Drive, Flinders Medical Centre, Bedford Park SA 5042
Country 152960 0
Australia
Phone 152960 0
+61 8 8204 5619
Fax 152960 0
Email 152960 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.