Relevance of Recording an ECG Trace With a Connected Watch

Официальное название

Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Smart watch
  ECG 1D/6D

Первичные конечные точки

• Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude [Срок оценки: 36 months]
• Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration [Срок оценки: 36 months]
• Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude [Срок оценки: 36 months]
• Comparison of electrical parameters measured using the 2 ECG methods: QRS duration [Срок оценки: 36 months]
• Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc [Срок оценки: 36 months]

Вторичные конечные точки (5)

• Creation of bank of anormal ECG trace [Срок оценки: 36 months]
• Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG [Срок оценки: 36 months]
• Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home [Срок оценки: 36 months]
• Validate the feasibility of recording an ECG trace with a connected watch for a child [Срок оценки: 36 months]
• Validate the sensibility of an ECG trace with a connected watch for a child [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Hôpital Haut-Lévèque — Pessac

Идентификаторы

NCT: NCT06272396 · CHUBX 2023/64

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗