Health TrialsbyHealthPanel

Relevance of Recording an ECG Trace With a Connected Watch

ConditionArrhythmias, Cardiac
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Bordeaux

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Smart watch

    Device

    ECG 1D/6D

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Smart watchExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude

Mean of P-wave amplitude

Time frame
36 months
2

Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration

Mean of P-wave duration

Time frame
36 months
3

Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude

Mean of QRS amplitude

Time frame
36 months
4

Comparison of electrical parameters measured using the 2 ECG methods: QRS duration

Mean of QRS duration

Time frame
36 months

Secondary outcomes

1

Creation of bank of anormal ECG trace

Number of ECG-1D/6D and 12 derivations

Time frame
36 months
2

Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG

Accuracy of diagnostic

Time frame
36 months
3

Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home

Number of ECG-1D/6D and 12 derivations

Time frame
36 months
4

Validate the feasibility of recording an ECG trace with a connected watch for a child

Number of ECG-1D/6D and 12 derivations

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov
Apply now