RecruitingNot ApplicableNCT06272396

Relevance of Recording an ECG Trace With a Connected Watch

Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch


Sponsor

University Hospital, Bordeaux

Enrollment

3,000 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria4

  • Patients hospitalized or seen in consultation in one of the departments of the Haut Lévêque 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, from the legal parent (at the latest on the day of inclusion and before any examination required for the research),
  • Subject affiliated to or benefiting from a social security regime.

Exclusion Criteria3

  • Person incapable of giving consent,
  • Person subject to a legal protection measure (safeguard of justice, tutorship or curatorship),
  • A person deprived of liberty by judicial or administrative decision.

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Interventions

DEVICESmart watch

ECG 1D/6D


Locations(1)

Hôpital Haut-Lévèque

Pessac, France

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NCT06272396


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