Atrial FibrillationWIBOFANCT06351761
WIBOFA - Validation of SCT02 With ECG-App for Detection of AF
A study testing Investigational Device (Withings SCT02) 30 second Electrocardiogram recording and Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording in people with Atrial Fibrillation, run by Withings at 4 sites in 2 countries.
Trial summary
The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Investigational Device (Withings SCT02) 30 second Electrocardiogram recording and Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Jun 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female who are 22 years of age or older
- Subject able to read, understand, and provide written informed consent
- Subject willing and able to participate in the study procedures as described in the consent form
- Subject able to communicate effectively with and willing to follow instructions from the study staff
Who cannot join
- Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive
- Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
- Myocardial Infarction (MI) within 90 days prior to the enrollment
- Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
- Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
- Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
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- Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
- Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis)
- Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
FWD Clinical Research
Boca Raton, Florida, 33486
Diverse Clinical Research
Miami, Florida, 33175
France2 sites
Henri Mondor University Hospital
Créteil, Val de Marne, 94000
Centre Cardiopole Trubert
Paris
About this study
Official title: Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation
The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
- Conditions
- Atrial Fibrillation
- Being tested
- Investigational Device (Withings SCT02) 30 second Electrocardiogram recording, Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Device (Withings SCT02) 30 second Electrocardiogram recordingDevice
30 second ECG recording with investigational device (Withings SCT02)
Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recordingDevice
30 second ECG recording with reference device (Schiller Cardiovit FT-1)
| Study group | Role | What they receive |
|---|---|---|
| Normal Sinus Rhythm | Experimental | Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices Receives: Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording |
| Atrial Fibrillation | Experimental | Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices Receives: Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording |
| Arrhythmia other than Atrial Fibrillation | Experimental | Simultaneous ECG recording of patient with Arrhythmia other than Atrial Fibrillation with investigational and reference devices Receives: Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary outcome 1 - Sensitivity of Investigational Device
Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
Measured: 10 months
Co-primary outcome 2 - Specificity of Investigational Device
Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
Measured: 10 months
Secondary outcomes (5)
Rhythm classification by ranges of heart rate
On pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the IMD is classified as either SR or AF, the classification into four heart rate subgroups will be evaluated.
- Sinus Rhythm, (50-99 bpm)
- High Heart Rate (No signs of AFib) (100-150 bpm)
- Atrial Fibrillation (50-99 bpm),
- Atrial Fibrillation (100-150 bpm)
Measured: 10 months
Quality of plots measured by the IMD - ECG Waveform Visibility
Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FV : Fraction of concordant assessments of visibility between the IMD and the reference
Measured: 10 months
Quality of plots measured by the IMD - ECG Waveforms Polarity
On waveforms with waves that are Visible, Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FP : Fraction of concordant assessment of polarity between IMD and reference
Measured: 10 months
Quality of plots measured by the IMD - ECG Waveforms Intervals
Determine the equivalence of PR, QRS and QT intervals durations between the lead I of the IMD and the lead I of the reference ECG determined by an independent board of certified cardiologists. Duration error will be calculated.
Measured: 10 months
Quality of plots measured by the IMD - Heart Rate calculation
Determine the equivalence of the heart rate (HR) calculated by the IMD and the HR measured by an independent board of certified cardiologists or cardiology technicians on the ECG of the reference.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start3 Jun 2024
- Primary completion10 Jun 2025
- Study completion26 Nov 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351761
- Sponsor's protocol ID
- SCT02-ECG
- Acronym
- WIBOFA
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
- Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06351761
- Acronym / sponsor ID
- WIBOFA / SCT02-ECG
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 8 Apr 2024 (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.
The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Sinus Rhythm | Experimental | Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording, Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recordingSimultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices |
| Atrial Fibrillation | Experimental | Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording, Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recordingSimultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices |
| Arrhythmia other than Atrial Fibrillation | Experimental | Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording, Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recordingSimultaneous ECG recording of patient with Arrhythmia other than Atrial Fibrillation with investigational and reference devices |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female who are 22 years of age or older
- Subject able to read, understand, and provide written informed consent
- Subject willing and able to participate in the study procedures as described in the consent form
- Subject able to communicate effectively with and willing to follow instructions from the study staff
Key exclusion criteria (9 listed)
- Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive
- Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
- Myocardial Infarction (MI) within 90 days prior to the enrollment
- Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
- Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
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 |
|---|---|---|
| Investigational Device (Withings SCT02) 30 second Electrocardiogram recording30 second ECG recording with investigational device (Withings SCT02) | Device | Arrhythmia other than Atrial Fibrillation, Atrial Fibrillation, Normal Sinus Rhythm |
| Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording30 second ECG recording with reference device (Schiller Cardiovit FT-1) | Device | Arrhythmia other than Atrial Fibrillation, Atrial Fibrillation, Normal Sinus Rhythm |
Primary outcome
Co-primary outcome 1 - Sensitivity of Investigational Device
Time frame: 10 months
Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
Co-primary outcome 2 - Specificity of Investigational Device
Time frame: 10 months
Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
5 secondary outcomes
Rhythm classification by ranges of heart rate
Time frame: 10 months
Quality of plots measured by the IMD - ECG Waveform Visibility
Time frame: 10 months
Quality of plots measured by the IMD - ECG Waveforms Polarity
Time frame: 10 months
Quality of plots measured by the IMD - ECG Waveforms Intervals
Time frame: 10 months
Quality of plots measured by the IMD - Heart Rate calculation
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Device (Withings SCT02) 30 second Electrocardiogram recording and Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording in people with Atrial Fibrillation, run by Withings at 4 sites in 2 countries.
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 4 inclusion and 9 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: finished, 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 4 sites in United States, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Co-primary outcome 1 - Sensitivity of Investigational Device (time frame: 10 months). The study lists 2 primary outcomes in all. 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.