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Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG - Trial NCT06420960

Access comprehensive clinical trial information for NCT06420960 through Pure Global AI's free database. This phase not specified trial is sponsored by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône and is currently Not yet recruiting. The study focuses on Heart Disease. Target enrollment is 81 participants.

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Trial Details
ClinicalTrials.govNCT06420960
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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.

Study Focus

Heart Disease

Wearing the connected watch

Interventional

device

Sponsor & Location

L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

Gleize, France

Timeline & Enrollment

N/A

Jun 17, 2024

Feb 17, 2027

81 participants

Primary Outcome

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

Summary

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.

ICD-10 Classifications

Heart disease, unspecified
Complications and ill-defined descriptions of heart disease
Other ill-defined heart diseases
Other forms of heart disease
Hypertensive heart disease

Data Source

ClinicalTrials.gov

NCT06420960

Device Trial