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AI-ECG Accessory Pathway Localisation Study

AI-ECG Accessory Pathway Localisation Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07083791
Acronym
AAPLS
Enrollment
100
Registered
2025-07-24
Start date
2025-08-01
Completion date
2027-03-01
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accessory Pathway, Artifical Intelligence, ECG

Keywords

AI-ECG, AI, ECG, Accessory pathway, Accessory pathway localisation

Brief summary

This study seeks to validate the real-world accuracy of an AI-based algorithm for identifying the location of an accessory pathway from the 12-lead electrocardiogram

Detailed description

Silent validation study of an AI-ECG (artificial intelligence applied to electrocardiography) accessory pathway localisation algorithm, applied to prospective and consecutive cases in clinical practice, to determine its true accuracy and performance. A pre-existing AI-ECG algorithm will be applied to participant ECG data, collected at the time of their clinical electrophysiology study (EPS) for ablation of their accessory pathway. This will be compared to the ground truth of the successful ablation location, determined by fluoroscopy and/or 3D electroanatomical mapping from their procedure.

Interventions

None listed

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Referred for EPS procedure as part of their clinical care, with a finding of pre-excitation on their ECG * Manifest pre-excitation on their ECG any time prior to their procedure * Able to give consent * Minimum age 13 years old * Maximum age 100 years old

Exclusion criteria

* Unable to give consent * Adults \> 100 years old * Children \< 13 years old * Patients with known location of their accessory pathway from a previous EP study

Design outcomes

Primary

MeasureTime frameDescription
Performance and accuracy of the AI-ECG accessory pathway localisation algorithmAt completion of recruitment, anticipated at 18 monthsPerformance metrics of the AI-ECG accessory pathway localisation algorithm, including accuracy, F1-score, sensitivity, specificity, positive and negative predictive values. Benchmarked against the ground truth of human operator assessment from fluoroscopy and/or 3D electroanatomical mapping.

Secondary

MeasureTime frameDescription
Accuracy of the ground truth locations from the human operator compared to the successful ablation locationAt completion of recruitment, anticipated at 18 monthsThe ground truth of successful ablation location determined by operator assessment of fluoroscopy ± 3D mapping will be compared to the true ablation location on a complete 3D electroanatomical annular map
Relative performance of the AI-ECG algorithm compared to human estimationAt completion of recruitment, anticipated at 18 monthsDifference in performance/accuracy between the AI-ECG accessory pathway localisation algorithm and human estimation from the 12-lead ECG
Relative performance of the AI-ECG algorithm compared to manual localisation algorithmsAt completion of recruitment, anticipated at 18 monthsDifference in performance/accuracy between the AI algorithm and pre-specified, established manual localisation algorithms (Arruda, Milstein, Pambrun, Boersma, D'Avila and Chiang)

Countries

United Kingdom

Contacts

Primary ContactKeenan Saleh, MBBS
keenan.saleh10@imperial.ac.uk+442033132243

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026