Clinical trial NCT06272396: Relevance of Recording an ECG Trace With a Connected Watch
Official title: Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmias, Cardiac
Keywords: Electrocardiogram
Smart watch
Arrhythmia
Artificial Intelligent
Remote monitoring
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude
timeFrame: 36 months
measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
timeFrame: 36 months
measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude
timeFrame: 36 months
measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS duration
timeFrame: 36 months
measure: Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc
timeFrame: 36 months
Secondary outcomes:
measure: Creation of bank of anormal ECG trace
timeFrame: 36 months
measure: Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG
timeFrame: 36 months
measure: Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home
timeFrame: 36 months
measure: Validate the feasibility of recording an ECG trace with a connected watch for a child
timeFrame: 36 months
measure: Validate the sensibility of an ECG trace with a connected watch for a child
timeFrame: 36 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre BORDACHAR
role: PRINCIPAL_INVESTIGATOR
References: