Arrhythmias, Cardiac
Conditions
Keywords
Electrocardiogram, Smart watch, Arrhythmia, Artificial Intelligent, Remote monitoring
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.
Interventions
DEVICESmart watch
ECG 1D/6D
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: P-wave amplitude | 36 months | Mean of P-wave amplitude |
| 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: QRS amplitude | 36 months | Mean of QRS amplitude |
| Comparison of electrical parameters measured using the 2 ECG methods: QRS duration | 36 months | Mean of QRS duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creation of bank of anormal ECG trace | 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 feasibility of recording an ECG trace with a connected watch for a child | 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 |
Countries
France
Contacts
Primary ContactPierre BORDACHAR
Outcome results
None listed