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Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Recruiting
18 years and older
All
Phase N/A

Overview

Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.

Description

Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess

  1. The presence or absence of atrial fibrillation
  2. if waveforms of ECG recorded with Move ECG compared with the reference.

Eligibility

Inclusion Criteria:

  • male or female who are 18 years or older
  • Subject who signed the written informed consent form

Exclusion Criteria:

  • Vulnerable subject with regard to regulations
  • Pregnant, parturient or breastfeeding woman,
  • Subject who is deprived of liberty by judicial, medical or administrative decision,
  • Underage subject,
  • Legally protected subject, or subject who is unable to sign the written informed consent form,
  • Subject who is not beneficiary or not affiliated to a social security scheme,
  • Subject within several of the above categories,
  • Subject who refused to participate in the study,
  • Subject in physical incapacity to wear a wrist-worn watch
  • Subject with electrical stimulation by pacemaker

Study details
    Arrhythmia
    Arrhythmia
    Atrial Fibrillation
    Atrial Fibrillation
    atrial fibrillation (pediatric)
    atrial fibrillation (pediatric)

NCT04493749

Withings

16 February 2024

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