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NCT06420960From ClinicalTrials.govRecruiting

Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

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

  • Heart Disease

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
Enrolment target
81
Started
15 April 2025
Main results due
18 January 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Hopitaux Nord-Ouest Villefranche Sur Saone

    Gleizé, France

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06420960. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG | Trialion