Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection (ECG-SW1)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: ECG measurement

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 Type: Observational
• Enrollment (Estimated): 234

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75015
      • Hôpital Européen Georges Pompidou
    • Paris, Île-de-France Region, France, 75008
      • Institut Cœur Paris Centre Turin
    • Saint-Denis, Île-de-France Region, France, 93200
      • Centre Cardiologique du Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

in and out patients from cardiology services

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
atrial fibrillation (AF); Patients diagnosed with AF during reference ECG	Diagnostic test: ECG measurement; Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG
sinus rhythm (SR); Patients diagnosed with SR during reference ECG	Diagnostic test: ECG measurement; Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Withings
• Investigators: Principal Investigator: Julien Nahum, Centre Cardiologique du Nord

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): March 15, 2021
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 2019-A013-58-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No