Relevance of Recording an ECG Trace With a Connected Watch
- Conditions
- Arrhythmias, Cardiac
- Interventions
- Device: Smart watch
- Registration Number
- NCT06272396
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Smart watch Smart watch ECG done with smart watch
- Primary Outcome Measures
Name Time Method Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration 36 months Mean of P-wave duration
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude 36 months Mean of P-wave amplitude
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude 36 months Mean of QRS amplitude
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc 36 months Mean of QT/QTc (corrected QT) intervals
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration 36 months Mean of QRS duration
- Secondary Outcome Measures
Name Time Method Creation of bank of anormal ECG trace 36 months Number of ECG-1D/6D and 12 derivations
Validate the feasibility of recording an ECG trace with a connected watch for a child 36 months Number of ECG-1D/6D and 12 derivations
Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG 36 months Accuracy of diagnostic
Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home 36 months Number of ECG-1D/6D and 12 derivations
Validate the sensibility of an ECG trace with a connected watch for a child 36 months Quality of ECG-1D/6D
Trial Locations
- Locations (1)
Hôpital Haut-Lévèque
🇫🇷Pessac, France