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Идёт набор NCT05573633

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

Без фазы С лечением Atrial Fibrillation Cardiac Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ECG, scanwatch.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation, Cardiac Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial

Обзор

The incidence of postoperative atrial fibrillation (POAF) after on-pump cardiac surgery remains high, at around 30%. POAF increases the risk of cardiac decompensation, stroke, acute myocardial infarction, and death, resulting in increased morbidity and mortality, hospital length of stay, and cost of patient management. Episodes of POAF are usually paroxysmal and asymptomatic, increasing the risk of developing permanent AF at five years by 4 to 5 times. POAF occurs between 3 and 4 days after cardiac surgery, mainly when the patient is hospitalized in a surgical ward without heart rate monitoring as opposed to critical care, where the patient benefits from continuous rhythmic monitoring. The diagnosis of POAF is therefore made with the help of a 12-lead electrocardiogram (ECG) when the patient presents clinical symptoms and when the medical staff notes a significant variation in heart rate. However, many patients with episodes of asymptomatic POAF have a higher risk of stroke and mortality than those with symptomatic POAF. Faced with this public health problem, the development of tools for diagnosing AF is in full swing, mainly the marketing of smartwatches (SWs) that allow for the performance of 1-lead ECG. SW is also equipped with algorithms to analyze heart rate variability and diagnose asymptomatic atrial fibrillation (AF) episodes. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommend the use of smartwatches to detect AF, in particular, to reduce the economic impact of AF. The aim of the study is to diagnose POAF within the first five days after patient discharge from the critical care unit for the cardiac surgery department.

Вмешательства

  • Процедура ECG
    the POAF will be diagnosed using a 12-lead ECG and according to the usual monitoring protocols for patients in the cardiac surgery department of Amiens University Hospital.
  • Процедура scanwatch
    POAF will be diagnosed with a Withings SM (ScanWatch) by a 1-lead ECG and/or 12-lead ECG.

Первичные конечные точки

  • Variation of POAF incidence between both groups [Срок оценки: 5 days]
Вторичные конечные точки (5)
  • percentage of asymptomatic POAF in the SW arm [Срок оценки: 5 days]
  • Association between POAF and left atrial reservoir strain [Срок оценки: At the enrollment in the study (day 0)]
  • Feasibility of rhythm monitoring using a smartwatch [Срок оценки: 5 days]
  • Cardiovascular prognosis assessed by the occurrence of major adverse cardiovascular events (MACE) [Срок оценки: 3 months and 6 months after inclusion]
  • Percentage of patients POAF after hospital discharge. [Срок оценки: 3 months and 6 months]

Критерии участия

Критерии включения

  • Adult patient (>18 years old)
  • The patient was hospitalized at Amiens University Hospital for on-pump cardiac surgery.
  • The patient has had a recent on-pump cardiac surgery (< 96h)
  • Patient with the motor and cognitive abilities to perform a 1-lead ECG with the smartwatch
  • The patient was transferred to the cardiac surgery department of Amiens University Hospital.
  • The beneficiary of a social security plan
  • Signature of the consent to participate in the study

Критерии исключения

  • History of AF
  • Need for rhythmic monitoring by telemetry in cardiac intensive care for atrioventricular block and rapid supra and ventricular rhythm disorder (>140 bpm).
  • An external pacemaker connected to epicardial electrodes depends on ventricular and atrial pacing.
  • Patients already included in an interventional clinical research protocol may alter the incidence of POAF.
  • Pregnant woman

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Франция · 1 центр
  • CHU Amiens Picardie — Amiens

Публикации

  • Beyls C, Hermida A, Mollet N, Vermander M, Noe F, Bara H, Josse E, Khamari M, Diouf M, Abou-Arab O, Mahjoub Y. Diagnosis of postoperative atrial fibrillation using smartwatch monitoring after cardiac surgery: protocol for the FAWATCH single-centre, open-label, randomised controlled trial. BMJ Open. 2026 Jul 17;16(7):e118691. doi: 10.1136/bmjopen-2026-118691. PMID 42468947

Идентификаторы

NCT: NCT05573633 · PI2021_843_0228

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗