Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06420960

Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

Led by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône · Updated on 2025-04-08

81

Participants Needed

1

Research Sites

96 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients consulting for palpitations without a previous arrhythmia diagnosis or with different current symptoms
  • Palpitations requiring cardiology consultation or emergency treatment
  • No suggestive diagnosis on resting 12-lead ECG
  • Non-contributory stress test if symptoms occur during exercise
  • Willingness to wear the connected watch except during charging
  • Use of compatible smartphone or tablet with internet access
  • Affiliated with a social security system
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Refusal to wear or use the connected watch provided
  • Inability to use the connected watch or lack of understanding
  • No smartphone available
  • Having an implantable device (pacemaker, ICD)
  • Known and treated arrhythmia with identical symptoms
  • Heart disease requiring implantable device for prevention
  • Associated syncope
  • Clear non-cardiac cause of symptoms
  • Pregnant or breastfeeding
  • Unable to complete follow-up due to geographic, language, social, or psychological reasons
  • Participation in another interfering clinical study
  • Under guardianship or deprived of liberty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopitaux Nord-Ouest Villefranche Sur Saone

Gleizé, France, 69400

Actively Recruiting

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Research Team

O

OLIVIER LE VAVASSEUR, MEDECINE

CONTACT

C

COLINE PERRIER, ARC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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