Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

ConditionHeart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorL'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Wearing the connected watch

    Device

    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.

Treatment groups

81 Participants
are divided into 2 treatment groups
Group A: connected watchExperimental treatment 1 intervention
Group B: HOLTER ECG 48 hoursActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter).

The investigators will compare the diagnostic performance of the connected watch with the HOLTER ECG, by identifying a symptomatic arrhythmia, , in the purpose of a faster and adapted cardiological management.

Time frame
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.

Secondary outcomes

1

Type of diagnosis recorded.

A diagnosis is defined by the documentation of an objective cardiac arrhythmia (focal atrial tachycardia/atrial fibrillation HR \>110 bpm/atrial fibrillation HR\<110 bpm/atrial flutter/junctional tachycardia/sustained or non-sustained ventricular tachycardia/peak tachycardia/sinus tachycardia/ventricular fibrillation/high-degree conduction disorder) concomitant with the symptomatology motivating the initial consultation.

Time frame
at 6 months or when the watch is returned if a diagnosis has been made.
2

Rate of concomitant diagnoses with either device

Symptomatic objective cardiac arrythmia recorded with the smarwatch, the HOLTER or the both

Time frame
at 6 months or when the watch is returned if a diagnosis has been made.
3

Rate of causal non-rhythmological diagnosis (symptoms without pathological per-critical ECG tracing)

Rate of ECGs failing to explain symptomatology (no ECG abnormality detected ECG) Time Frame : 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.

Time frame
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.
4

Medical/paramedical time per diagnosis and per patient

Fitting of holter ECG equipment, handover of watch and explanation of how it works, analysis of holter/ ECG tracings, reconsultation)

Time frame
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.

Other outcomes

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