Use of the ECG Watch in Palpitation Assessment: Feasibility Study

Обзор

Palpitations are the cause of 16% of reasons for consultation with the general practitioner. 41% of palpitations are secondary to cardiac arrhythmia. If a rhythm or conduction disorder is recorded in a symptomatic context, then the cardiac origin can be validated or invalidated. The challenge therefore consists of obtaining an ECG trace during an attack of palpitations (per-critical ECG). Since patients are rarely symptomatic during consultations, additional exploration by ambulatory electrocardiographic recording is essential. To date, the 24-hour Holter ECG is currently the most used in current practice, only has a sensitivity of 22 to 35% maximum depending on the studies. We hypothesize that the ECG watch is a reliable medical tool in the etiological assessment of palpitations, with at least 90% of traces interpretable. The main objective of this study is to validate the use of the ScanWatch watch (Withings®) in the assessment of palpitations.

Подробное описание

The following examinations will be carried out:

* After inclusion: Information on the operation of the connected watch, loan of the watch, and implementation of a 14-day Spider Flash. * For a minimum of 14 days to 1 month, the patient will wear the connected watch, and activate it during an attack of palpitations. For 14 days, he will be concomitantly equipped with a Spider Flash. * All of the watch's traces will be automatically transferred to the Withings RPM data visualization platform independent of each center. The traces will then be centralized anonymously to analyze the results. * At the end of the loan period, the patient then returns the watch to the cardiology department of their reference center. The Spider Flash is removed after 14 days. * The patient will be summoned to carry out additional examinations or make therapeutic modifications according to the results of these examinations as part of routine care by their reference center.

Вмешательства

• Устройство ECG watch
  ECG watch in palpitation assessment

Первичные конечные точки

• Concordance between the number of per-critical tracings obtained via the connected watch (explanatory variable) and the number of interpretable tracings obtained (dependent variable) [Срок оценки: One month]

Вторичные конечные точки (3)

• Average number of traces per critical necessary to obtain an interpretable trace with the Spider Flash and the connected watch. [Срок оценки: One month]
• Average time to obtain a per critical trace [Срок оценки: One month]
• Classification of recorded events [Срок оценки: One month]

Критерии участия

Критерии включения

• Adult patient, male or female, referred for cardiological consultation for assessment of palpitations, after which an outpatient electrocardiographic exploration is carried out by the cardiologist.
• \- Patient presenting at least 1 palpitation attack per month over the last 3 months or at least 1 palpitation attack per week over the last month.
• Patient equipped with a smartphone compatible with the HealthMate application.
• Able to give consent to participate in research.
• Affiliation to a social security regime.

Критерии исключения

• Patient physically or mentally unable to make a recording using the connected watch.
• Patient contraindicated for the application of skin patches.
• Patient with pacemaker or defibrillator.
• Pregnant or breastfeeding women
• Patients of legal age under protective supervision
• Refusal to participate

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

Диагностика

Центры проведения

Франция · 1 центр

• CHU Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07121816 · AOI 2023 ABU ALRUB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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