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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Smart watch

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre BORDACHAR; Phone Number: +335 57 65 64 71; Email: pierre.bordachar@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • Recruiting
    • Hôpital Haut-Lévêque
    • Contact: Pierre BORDACHAR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart watch; ECG done with smart watch	Device: Smart watch; ECG 1D/6D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude	Mean of P-wave amplitude	36 months
Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration	Mean of P-wave duration	36 months
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude	Mean of QRS amplitude	36 months
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration	Mean of QRS duration	36 months
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc	Mean of QT/QTc (corrected QT) intervals	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of bank of anormal ECG trace	Number of ECG-1D/6D and 12 derivations	36 months
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
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
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
Validate the sensibility of an ECG trace with a connected watch for a child	Quality of ECG-1D/6D	36 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Pierre BORDACHAR, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): March 26, 2028

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Arrhythmia; Electrocardiogram; Remote monitoring; Smart watch; Artificial Intelligent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CHUBX 2023/64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No