Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
时间窗: 36 months
Mean of P-wave duration
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude
时间窗: 36 months
Mean of P-wave amplitude
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude
时间窗: 36 months
Mean of QRS amplitude
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc
时间窗: 36 months
Mean of QT/QTc (corrected QT) intervals
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration
时间窗: 36 months
Mean of QRS duration
次要结局
- Creation of bank of anormal ECG trace(36 months)
- Validate the feasibility of recording an ECG trace with a connected watch for a child(36 months)
- Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG(36 months)
- Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home(36 months)
- Validate the sensibility of an ECG trace with a connected watch for a child(36 months)