Atrial FibrillationECG-SW1NCT04493749
Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
An observational study of Atrial Fibrillation, run by Withings at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ECG measurement
- How many people
- 234 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Dec 2019to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in and out patients from cardiology services
Who may be able to join
- male or female who are 18 years or older
- Subject who signed the written informed consent form
Who cannot join
- 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,
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Cœur Paris Centre Turin
Paris, Île-de-France Region, 75008
Hopital Europeen Georges Pompidou
Paris, Île-de-France Region, 75015
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, 93200
About this study
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.
Read the 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
- The presence or absence of atrial fibrillation
- if waveforms of ECG recorded with Move ECG compared with the reference.
- Conditions
- Atrial Fibrillation
- Being tested
- ECG measurement
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG measurementDiagnostic test
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation (AF) | Patients diagnosed with AF during reference ECG Receives: Diagnostic Test: ECG measurement | |
| sinus rhythm (SR) | Patients diagnosed with SR during reference ECG Receives: Diagnostic Test: ECG measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
Safety of use of Move ECG
Frequency of adverse event appearance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start20 Dec 2019
- Primary completion15 Mar 2021
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Nahum, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493749
- Sponsor's protocol ID
- 2019-A013-58-49
- Acronym
- ECG-SW1
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2020
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
- ClinicalTrials.gov ID
- NCT04493749
- Acronym / sponsor ID
- ECG-SW1 / 2019-A013-58-49
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The presence or absence of atrial fibrillation
- if waveforms of ECG recorded with Move ECG compared with the reference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation (AF) | – | Diagnostic Test: ECG measurementPatients diagnosed with AF during reference ECG |
| sinus rhythm (SR) | – | Diagnostic Test: ECG measurementPatients diagnosed with SR during reference ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in and out patients from cardiology services
Key inclusion criteria (2 listed)
- male or female who are 18 years or older
- Subject who signed the written informed consent form
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG measurementSimultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG | Diagnostic test | atrial fibrillation (AF), sinus rhythm (SR) |
Primary outcome
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'
2 secondary outcomes
Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG
Time frame: 1 year
Safety of use of Move ECG
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Nahum principal investigator
Centre Cardiologique du Nord
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Withings at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.