Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
ECG-SW1
1 other identifier
observational
234
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2019
CompletedFirst Submitted
Initial submission to the registry
July 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2026
ExpectedFebruary 18, 2026
February 1, 2026
1.2 years
July 27, 2020
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG
1 year
Safety of use of Move ECG
1 year
Study Arms (2)
atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
sinus rhythm (SR)
Patients diagnosed with SR during reference ECG
Interventions
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG
Eligibility Criteria
in and out patients from cardiology services
You may qualify if:
- male or female who are 18 years or older
- Subject who signed the written informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Withingslead
Study Sites (3)
Institut Cœur Paris Centre Turin
Paris, Île-de-France Region, 75008, France
Hopital Europeen Georges Pompidou
Paris, Île-de-France Region, 75015, France
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, 93200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien Nahum
Centre Cardiologique du Nord
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2020
First Posted
July 30, 2020
Study Start
December 20, 2019
Primary Completion
March 15, 2021
Study Completion (Estimated)
October 15, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share