Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: ECG measurement

• Registration Number: NCT04493749
• Lead Sponsor: Withings

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-12-20
• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
atrial fibrillation (AF)	ECG measurement	Patients diagnosed with AF during reference ECG
sinus rhythm (SR)	ECG measurement	Patients diagnosed with SR during reference ECG

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG	1 year	sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

Secondary Outcome Measures

Name	Time	Method
Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG	1 year	Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate
Safety of use of Move ECG	1 year	Frequency of adverse event appearance

Trial Locations

Locations (3)

Institut Cœur Paris Centre Turin; 🇫🇷 Paris, Ile-de-France, France

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, Ile-de-France, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, Ile-de-France, France