Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

Launched by L'HÔPITAL NORD-OUEST - VILLEFRANCHE VILLEFRANCHE SUR SAÔNE · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a connected watch that monitors heart activity compares to a traditional 48-hour Holter ECG in identifying the cause of palpitations, which are irregular heartbeats that many people experience. Palpitations can be tricky to diagnose because they often happen randomly, and patients may not show symptoms during a doctor's visit. The trial aims to find out which method is more effective and cost-efficient for diagnosing heart issues within six months after a cardiology consultation.

To be eligible for the study, participants must be adults experiencing palpitations that require medical attention, and they should not have a previously diagnosed arrhythmia unless their current symptoms are different. They will need to agree to wear the connected watch regularly and use a compatible smartphone or tablet to track their heart activity. Participants can expect to wear the watch for most of the day, except when it needs charging, and will be monitored for any changes in their heart rhythms. This research could help improve how palpitations are diagnosed and managed in the future.

Gender

ALL

Eligibility criteria

• 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.