An interventional study of Wearing the connected watch in Heart Disease, sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study
Device: Wearing the connected watch
All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study
Device: Wearing the connected watch
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.
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.
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.
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.
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.
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.
Plan to share: Undecided — Confidentiality and Privacy: Sharing IPD data could compromise the confidentiality and privacy of participants. Individual data, even anonymized, could potentially be used to identify individuals, particularly in the case of small cohorts or sensitive data. Data Sensitivity: IPD data includes sensitive health information. Sharing such data is subject to strict data protection regulations and requires additional measures to ensure security and confidentiality. Resources and Costs: Sharing IPD data requires additional resources for anonymization, management, and data provision. We do not have the necessary resources to perform these tasks due to our limited budget.
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L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône