Relevance of Recording an ECG Trace With a Connected Watch

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

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2028-03-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmias, Cardiac

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smart watch

ECG done with smart watch

Group Type EXPERIMENTAL

Smart watch

Intervention Type DEVICE

ECG 1D/6D

Interventions

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Smart watch

ECG 1D/6D

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No