AI-ECG Accessory Pathway Localisation Study

NCT ID: NCT07083791

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-03-01

Brief Summary

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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

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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.

Conditions

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Accessory Pathway Artifical Intelligence ECG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with manifest pre-excitation

Patients with a previous ECG demonstrating manifest pre-excitation, referred for an electrophysiology study as part of their clinical care

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahran Arnold, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Keenan Saleh, MBBS

Role: CONTACT

+442033132243

Facility Contacts

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Keenan Saleh, MBBS

Role: primary

02033132243

Ahran Arnold, PhD

Role: backup

02033132243

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRAS 347921

Identifier Type: -

Identifier Source: org_study_id

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