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.
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3,000
ECG 1D/6D
Hôpital Haut-Lévèque
Pessac, France
RECRUITINGComparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude
Mean of P-wave amplitude
Time frame: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
Mean of P-wave duration
Time frame: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude
Mean of QRS amplitude
Time frame: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration
Mean of QRS duration
Time frame: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc
Mean of QT/QTc (corrected QT) intervals
Time frame: 36 months
Creation of bank of anormal ECG trace
Number of ECG-1D/6D and 12 derivations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 36 months
Validate the sensibility of an ECG trace with a connected watch for a child
Quality of ECG-1D/6D
Time frame: 36 months
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