AI-ECG Accessory Pathway Localisation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Accessory Pathway, Artifical Intelligence, ECG. Basic parameters: 13 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Performance and accuracy of the AI-ECG accessory pathway localisation algorithm [Time frame: At completion of recruitment, anticipated at 18 months]
Secondary outcome measures (3)
- Relative performance of the AI-ECG algorithm compared to human estimation [Time frame: At completion of recruitment, anticipated at 18 months]
- Relative performance of the AI-ECG algorithm compared to manual localisation algorithms [Time frame: At completion of recruitment, anticipated at 18 months]
- Accuracy of the ground truth locations from the human operator compared to the successful ablation location [Time frame: At completion of recruitment, anticipated at 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust — London
Identifiers
NCT: NCT07083791 · IRAS 347921