Relevance of Recording an ECG Trace With a Connected Watch (ECG-MC)

University Hospital of Bordeaux

Status

Enrolling

Conditions

Arrhythmias, Cardiac

Treatments

Device: Smart watch

Study type

Interventional

Funder types

Other

Identifiers

NCT06272396

CHUBX 2023/64

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.