Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

Официальное название

Rentabilité Diagnostique Des Montres connectées Par Rapport au Holter ECG Externe Dans l'Expertise Des Palpitations Fugaces Symptomatiques Sans Documentation électrocardiographique Per Critique.

Обзор

Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department. Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity. The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of consultation, the patient is often asymptomatic. The initial strategy is to demonstrate an electrocardiographic trace during the attack, in order to adapt management to the chosen etiology. The HOLTER ECG is the gold standard, but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms. The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms. They are widely adopted by the general population, with ease of use by the individual and long monitoring times. The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies (rate of identification of the causal arrhythmia) at 6 months from the cardiological consultation.

Вмешательства

• Устройство Wearing the connected watch
  All patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address. They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance.

Первичные конечные точки

• Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter). [Срок оценки: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.]

Вторичные конечные точки (4)

• Type of diagnosis recorded. [Срок оценки: at 6 months or when the watch is returned if a diagnosis has been made.]
• Rate of concomitant diagnoses with either device [Срок оценки: at 6 months or when the watch is returned if a diagnosis has been made.]
• Rate of causal non-rhythmological diagnosis (symptoms without pathological per-critical ECG tracing) [Срок оценки: at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.]
• Medical/paramedical time per diagnosis and per patient [Срок оценки: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.]

Критерии участия

Критерии включения

• Any patient consulting for the main reason of palpitations; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis;
• Palpitations requiring cardiological consultation or emergency hospital treatment;
• Absence of suggestive diagnosis on intercritical 12-lead ECG (pre-excitation, AVB M2/3, high-grade atrioventricular block, non-sustained tachyventricular, atrial fibrillation with heart rate; 110 per minute, atrial tachycardia or flutter);
• Non-contributory stress test (no electrical abnormality, occurrence of arrhythmia or reproduction of palpitations) if isymptoms occur during exercise;
• Accepts to wear the watch all the time outside the charging time;
• Using a personal smartphone or tablet compatible with the Health Mate application and with an Internet connection;
• Affiliated with a social security system ;
• Providing dated and signed an informed consent form.

Критерии исключения

• Refusal to wear the connected watch;
• Refusal to use the watch provided for the study because they use a personal connected watch;
• Unable to use the connected watch (lack of understanding of its use and rationale);
• No smartphone;
• Wearer of an implantable device (PM, ICD);
• Already known and treated arrhythmia with identical symptoms;
• Heart disease with indication for primary/secondary prevention implantable device;
• Associated syncope;
• Obvious extra-cardiac cause;
• Pregnant or breast-feeding woman;
• Inability to undergo study follow-up for geographical, linguistic, social or psychological reasons;
• Participating in another clinical study which can interfere with this study
• Patient under guardianship or deprived of liberty.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Hopitaux Nord-Ouest Villefranche Sur Saone — Gleizé

Идентификаторы

NCT: NCT06420960 · HNO23_0001 · 2023-A01853-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗