Comparing ECG readings from connected watches to traditional Holter ECGs for heart disease diagnosis

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

This study tests if ECG readings from smartwatches can help diagnose heart disease better than traditional Holter monitors in people who have palpitations.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône (Academic / other)
• Locations: 1 site (Gleizé)
• Trial ID: NCT06420960 on ClinicalTrials.gov

What this trial studies

This study evaluates the diagnostic effectiveness of ECG readings obtained from connected watches compared to traditional 48-hour Holter ECGs in patients experiencing palpitations. It aims to address the challenges of diagnosing transient symptoms that often occur when patients are asymptomatic during consultations. By utilizing connected watches, which are more accessible and user-friendly, the study seeks to provide continuous monitoring and potentially capture critical ECG traces during episodes of palpitations. The goal is to improve diagnostic yield and management strategies for heart disease.

Who should consider this trial

Good fit: Ideal candidates include patients consulting for palpitations without a prior arrhythmia diagnosis and who require cardiological evaluation.

Not a fit: Patients with a known arrhythmia diagnosis that aligns with their current symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of heart conditions related to palpitations.

How similar studies have performed: While traditional Holter ECGs are well-established, the use of connected watches for ECG monitoring is a novel approach that has not been extensively tested in this context.

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.

Where this trial is running

Gleizé

• Hopitaux Nord-Ouest Villefranche Sur Saone — Gleizé, France (Recruiting)

Study contacts

• Study coordinator: Olivier Le Vavasseur, Medecine

Conditions Heart Disease; palpitations; yield diagnostic; connected watch; device; HOLTER ECG; monitoring; profitability