Atrial FibrillationQDA-UENCT05266235
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
A study testing Validation of the Withings bodyscan scale WBS08 in people with Atrial Fibrillation, run by Withings at 4 sites in 2 countries.
Trial summary
The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Validation of the Withings bodyscan scale WBS08
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Apr 2022to 28 Jul 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female who are 18 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
- Subject affiliated to a social security system
- For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening. Subjects may have any type of AF including paroxysmal, persistent, and permanent AF.
Who cannot join
- Vulnerable subject with regard to regulations in force :
- Subject who is deprived of liberty by judicial, medical or administrative decision,
- Underage subject,
- Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form
- Subject within several of the above categories
- Subject who refused to participate in the study
Show all 18Show fewer
- Subject mentally impaired resulting in limited ability to cooperate
- Subject with a pacemaker, ICD (Implantable cardioverter defibrillator) or other implanted electronic stimulator
- Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being ablle to hold still (e.g Parkinson disease)
- Patient unable to stay in an upright position for the duration of study measures
- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, may increase the risk to the subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
- Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
- Stroke or transient ischemic attack within 90 days of screening
- Active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3rd degree heart block).
- History of abnormal life-threatening rhythms as determined by the investigator (e.g., ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites
- Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands
- Weight more than 180 kg
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Henri Mondor University Hospital
Créteil, Val De Marne, 94000
George Pompidou European Hospital
Paris, 75015
Poitiers University Hospital
Poitiers, Vienne, 86021
Belgium1 site
Cliniques Universitaires de Bruxelles - Hôpital Erasme
Brussels, 1070
About this study
The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.
Read the detailed description
Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.
- Conditions
- Atrial Fibrillation
- Being tested
- Validation of the Withings bodyscan scale WBS08
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the Withings bodyscan scale WBS08Device
Participants will undergo simultaneous recordings of ECGs with the comparator and the study device
| Study group | Role | What they receive |
|---|---|---|
| Withings WBS08 and 12-lead reference ECG | Experimental | The electrodes of the 12-lead ECG will be set up on the participants, before they step on withings WBS08 to have ECGs simultaneously recorded by the study device and the control device Receives: Device: Validation of the Withings bodyscan scale WBS08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in the identification of atrial fibrillation and sinus rhythm
The co-primary endpoints are the sensitivity and specificity 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 SUT, compared to the reference 12-lead ECG.
Measured: 10 months
Secondary outcomes (4)
Evaluation of the classification into heart rate subgroups
The classification into heart rate subgroups will be evaluated for the 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 SUT is classified as either SR or AF and such that the strip generated by the SUT is classified as either SR or AF. The evaluation will be assessed with the concordance of classifications, i.e. the percentage P of identical classifications by the SUT and the reference method, into each of the four following subgroups :
- SR with a HR between 50 and 99 bpm
- SR with a HR between 100 and 150 bpm
- AF with a HR between 50 and 99 bpm
- AF with a HR between 100 and 150 bpm
Measured: 10 months
Assessment of the clinical equivalence of ECG waveforms
Clinical equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 6-leads generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG by a board of certified cardiologists : The visibility and polarity of the P waves, QRS complexes and T waves will be determined by cardiologists and according to a set of predetermined rules.
Measured: 10 months
Assessment of the clinical equivalence of ECG waveforms
The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper on the first beat of the 6 marked PQRST complexes and according to a set of predetermined rules for each of the 6 leads of the strips generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG.
Measured: 10 months
Determination of the heart rate
The heart rate will be determined by independent cardiologists, or cardiac technicians supervised by cardiologists, from each six-channel strip recorded with the SUT and from each lead I, II, III, aVR, aVL, aVF of the 12-lead strip of the reference ECG. For each simultaneous pair of strips, a reviewer will independently select a common lead with the best signal quality. Then, the reviewer will determine one or several window(s) on the selected lead according to a set of predetermined rules. Finally the number N of complete RR intervals inside these windows and the duration Dt (< 30s) of the windows will be measured with a caliper. The heart rate will then be calculated as 60*N/Dt. The reader-estimated heart rates will later be compared to the heart rates calculated by the SUT
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 posted4 Mar 2022
- Study start14 Apr 2022
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Lellouche, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266235
- Sponsor's protocol ID
- 2021-A02730-41
- Acronym
- QDA-UE
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2022
- Last updated
- 28 Mar 2023
- Results posted
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05266235
- Acronym / sponsor ID
- QDA-UE / 2021-A02730-41
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 4 Mar 2022 (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 demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.
Detailed description
Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Withings WBS08 and 12-lead reference ECG | Experimental | Device: Validation of the Withings bodyscan scale WBS08The electrodes of the 12-lead ECG will be set up on the participants, before they step on withings WBS08 to have ECGs simultaneously recorded by the study device and the control device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female who are 18 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
- Subject affiliated to a social security system
Key exclusion criteria (18 listed)
- Vulnerable subject with regard to regulations in force :
- Subject who is deprived of liberty by judicial, medical or administrative decision,
- Underage subject,
- Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form
- Subject within several of the above categories
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 |
|---|---|---|
| Validation of the Withings bodyscan scale WBS08Participants will undergo simultaneous recordings of ECGs with the comparator and the study device | Device | Withings WBS08 and 12-lead reference ECG |
Primary outcome
Performance in the identification of atrial fibrillation and sinus rhythm
Time frame: 10 months
The co-primary endpoints are the sensitivity and specificity 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 SUT, compared to the reference 12-lead ECG.
4 secondary outcomes
Evaluation of the classification into heart rate subgroups
Time frame: 10 months
Assessment of the clinical equivalence of ECG waveforms
Time frame: 10 months
Assessment of the clinical equivalence of ECG waveforms
Time frame: 10 months
Determination of the heart rate
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 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Nicolas Lellouche, MD principal investigator
Henri Mondor University Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation of the Withings bodyscan scale WBS08 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 6 inclusion and 18 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 28 Mar 2023. 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 France, Belgium. 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?
Performance in the identification of atrial fibrillation and sinus rhythm (time frame: 10 months). 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 28 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.