Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05829993

Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-31

5000

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

UMMISCO - Institute of Research for Development (IRD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an artificial intelligence (AI) model designed to detect pathological repolarization disorders on electrocardiograms (ECG) and predict the risk of ventricular arrhythmias, specifically Torsades de Pointes (TdP) related to Long QT (LQT) syndromes. These conditions can be congenital or drug-induced, affecting cardiac ion channels and prolonging ventricular repolarization, which increases the risk of dangerous arrhythmias. Current screening methods rely mainly on QTc interval measurement and genetic testing, which have limitations in real-world clinical practice. The AI model aims to improve the detection and classification of LQT types and TdP risk by analyzing ECG features beyond QTc alone. This observational study will collect digital ECG data, clinical history, medication use, and genetic information from 5,000 participants across multiple hospitals. The AI model automatically measures ECG parameters such as QTc, PR, QRS duration, and heart rate, and provides probabilistic scores for different congenital and drug-induced LQT types and TdP risk. Data analysis compares AI measurements with reference methods to validate the model's performance in real-world conditions. ECGs are anonymized and centrally stored for analysis during this 42-month study. Participants are patients who require an ECG as part of their routine care or research involvement and have no contraindications for ECG. The study measures the agreement between AI and reference QTc measurements and evaluates the accuracy of AI scores for LQT types and TdP risk on the day of ECG recording. The goal is to enhance real-time ECG interpretation and risk classification to improve arrhythmia management, particularly in settings without specialized rhythmology expertise. The total participation involves a single ECG assessment with data collection from clinical and genetic records.

CONDITIONS

Brief Title

Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients or subjects receiving care in recruiting centers where an ECG is indicated
  • No opposition to participation in the study
Not Eligible

You will not qualify if you...

  • Medical contraindication for ECG
  • Subjects with pacemaker-driven QRS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day 0

Participants undergo ECG recordings and clinical data collection to evaluate repolarization disorders using artificial intelligence analysis.

1 visit (in-person) for ECG and data collection

Long-term Monitoring

Duration - Up to 42 months

Participants' digital ECGs and clinical data are analyzed to validate the AI model's performance in real-world clinical practice.

No additional visits required; analysis is based on collected data

Trial Site Locations

Total: 1 location

1

Centre d'Investigation Clinique Paris-Est/Hôpital Pitié-Salpêtrière

Paris, France, 75013

Actively Recruiting

Loading map...

Research Team

J

Joe-Elie SALEM, PU-PH

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Arrhythmic Mitral Valve Prolapse Detection Using Long-term A...

Mitral Valve Prolapse

Actively Recruiting

1 location

Bipolar Radio-frequency Ablation After Standard Unipolar App...

Ventricular Arrythmia

Actively Recruiting

1 location

BoStOn SCientific Rhythm MAnagemenT REgiStry

Cardiac Disease

Actively Recruiting

26 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here