Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Europeen Georges Pompidou, Paris, Île-de-France Region, France

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG measurement

Diagnostic Test

Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

Primary outcomes

Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG

Time frame: 1 year

sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

Secondary outcomes

Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG

Time frame: 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

Time frame: 1 year

Frequency of adverse event appearance

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Acronym: ECG-SW1

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2026
First posted: Jul 30, 2020
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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