Relevance of Recording an ECG Trace With a Connected Watch
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart watch.
- Who it may be relevant to
- Registry conditions: Arrhythmias, Cardiac. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
Overview
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.
Interventions
- Device Smart watch
ECG 1D/6D
Primary outcome measures
- Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude [Time frame: 36 months]
- Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration [Time frame: 36 months]
- Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude [Time frame: 36 months]
- Comparison of electrical parameters measured using the 2 ECG methods: QRS duration [Time frame: 36 months]
- Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc [Time frame: 36 months]
Secondary outcome measures (5)
- Creation of bank of anormal ECG trace [Time frame: 36 months]
- Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG [Time frame: 36 months]
- Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home [Time frame: 36 months]
- Validate the feasibility of recording an ECG trace with a connected watch for a child [Time frame: 36 months]
- Validate the sensibility of an ECG trace with a connected watch for a child [Time frame: 36 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Hôpital Haut-Lévèque — Pessac
Identifiers
NCT: NCT06272396 · CHUBX 2023/64