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Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

RecruitingNAAges 18 Years - anyAllL'hôpital Nord-Ouest - Villefranche Villefranche …
NCT06420960 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ado

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Wearing the connected watch
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Where

1 site
Hopitaux Nord-Ouest Villefranche Sur Saone
Gleizé, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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