NCT06420960

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.
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Heart Disease
Drug/Device/Intervention
Wearing the connected watch
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
Location
Gleize, France
Timeline & enrollment
Phase
N/A
Start date
Jun 17, 2024
End date
Feb 17, 2027
Enrollment
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, unspecifiedComplications and ill-defined descriptions of heart diseaseOther ill-defined heart diseasesOther forms of heart diseaseHypertensive heart disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06420960
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.