Relevance of Recording an ECG Trace With a Connected Watch

Last updated: March 28, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

Smart watch

Clinical Study ID

NCT06272396
CHUBX 2023/64
  • All Genders

Study Summary

Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single (1D) or six derivations (6D) can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an intracardiac defibrillator (ICD) may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients hospitalized or seen in consultation in one of the departments of the HautLévêque cardiology hospital,

  • Patient of both sexes, minor (from birth to 18 years) or adult,

  • Free, informed and written consent from the patient or, in the case of minors, fromthe legal parent (at the latest on the day of inclusion and before any examinationrequired for the research),

  • Subject affiliated to or benefiting from a social security regime.

Exclusion

Exclusion Criteria:

  • Person incapable of giving consent,

  • Person subject to a legal protection measure (safeguard of justice, tutorship orcuratorship),

  • A person deprived of liberty by judicial or administrative decision.

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Smart watch
Phase:
Study Start date:
March 26, 2024
Estimated Completion Date:
March 26, 2028

Study Description

Single-arm prospective study to evaluate the measurement of electrocardiographic parameters obtained using two non-invasive ECG methods, one 12-lead reference method and the second 1 or 6 leads recorded from a connected watch, in a group of patients with healthy hearts (normal ECG) and 19 pathological groups.

Connect with a study center

  • Hôpital Haut-Lévèque

    Pessac, 33604
    France

    Active - Recruiting

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