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

Arrhythmias, Cardiac Clinical Trial

— ECG-MC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272396
• Other study ID #: CHUBX 2023/64
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: March 20, 2028

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: Pierre BORDACHAR
• Phone: +335 57 65 64 71
• Email: pierre.bordachar[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 or six derivations 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: March 20, 2028
• Est. primary completion date: March 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• Smart watch
ECG 1D/6D

Locations

Country	Name	City	State
France	Hôpital Haut-Lévèque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude	Mean of P-wave amplitude	36 months
Primary	Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration	Mean of P-wave duration	36 months
Primary	Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude	Mean of QRS amplitude	36 months
Primary	Comparison of electrical parameters measured using the 2 ECG methods: QRS duration	Mean of QRS duration	36 months
Primary	Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc	Mean of QT/QTc	36 months
Secondary	Creation of bank of anormal ECG trace	Number of ECG-1D/6D and 12 derivations	36 months
Secondary	Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG	Accuracy of diagnostic	36 months
Secondary	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	36 months
Secondary	Validate the feasibility of recording an ECG trace with a connected watch for a child	Number of ECG-1D/6D and 12 derivations	36 months
Secondary	Validate the sensibility of an ECG trace with a connected watch for a child	Quality of ECG-1D/6D	36 months