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Идёт набор NCT06164808

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Без фазы С лечением Cardiac Arrhythmia Diagnostic/Monitoring Devices Related to Adverse Incidents Atrial Fibrillation (AF)

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: HeartWatch.
Кому может быть актуально
Состояния в реестре: Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF). Базовые параметры: от 22 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
Канада
Следующий шаг
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Обзор

Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

Подробное описание

Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.

Вмешательства

  • Устройство HeartWatch
    The HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope, and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone whe

Первичные конечные точки

  • QRS signal detection [Срок оценки: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours]
Вторичные конечные точки (4)
  • ECG strip evaluation [Срок оценки: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]
  • ECG PR interval assessment [Срок оценки: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]
  • ECG QRS interval assessment [Срок оценки: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]
  • ECG interval assessment [Срок оценки: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).]

Критерии участия

Критерии включения

  • At least 22 years of age at time of consent
  • Clinically indicated for a Holter monitor test
  • Able to wear the HeartWatch on the left bicep for the study duration
  • Able to follow the protocol
  • No functional implantable pacemaker or defibrillator
  • Left bicep circumference >/= 22 cm and </= 45 cm
  • Provision of written-informed consent

Критерии исключения

  • Known allergy to any component of the Holter monitor
  • Known allergy to any component of the HeartWatch
  • Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
  • Dextrocardia
  • Implanted functional Pacemaker or Defibrillator
  • Left bicep circumference < 22 cm
  • Left bicep circumference < 45 cm

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

Канада · 1 центр
  • Foothills Medical Centre University of Calgary — Calgary

Идентификаторы

NCT: NCT06164808 · CATCH V3.1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗