Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Last updated: July 27, 2020
Sponsor: Withings
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT04493749
2019-A013-58-49
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female who are 18 years or older

  • Subject who signed the written informed consent form

Exclusion

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 informedconsent 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 Design

Total Participants: 234
Study Start date:
December 20, 2019
Estimated Completion Date:
October 15, 2020

Study 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.

Connect with a study center

  • Hopital Europeen Georges Pompidou

    Paris, Ile-de-France 75015
    France

    Completed

  • Institut Cœur Paris Centre Turin

    Paris, Ile-de-France 75008
    France

    Active - Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, Ile-de-France 93200
    France

    Completed

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