Atrial FibrillationNCT05316337
Withings ECG-Monitor Study
A study testing Electrocardiogram recording in people with Atrial Fibrillation, run by Withings at 10 sites in 2 countries.
Trial summary
The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Electrocardiogram recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Jul 2022to 1 Sep 2023
- 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
- No healthy volunteers
- 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
- 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 electrical stimulation by pacemaker
- Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able 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, 3 rd -degree heart block).
- History of life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -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
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Cambridge Medical Trials
Alexandria, Louisiana, 71301
FWD Clinical Research
Boca Raton, Florida, 33486
Florida Cardiovascular Research
Hialeah, Florida, 33012
Texas Heart Institute
Houston, Texas, 77030
American Institute of Therapeutics
Lake Bluff, Illinois, 60044
Diverse Clinical Research
Miami, Florida, 33175
The Angel Medical Research
Miami Lakes, Florida, 33016
Heartbeat Health
New York, New York, 10019
LINQ Research LLC
Pearland, Texas, 77584
About this study
Official title: Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation
The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation
- Conditions
- Atrial Fibrillation
- Being tested
- Electrocardiogram recording
- Keywords
- mHealth, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram recordingDevice
ECG recording with investigational device
Electrocardiogram recordingDevice
ECG recording with reference device
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Experimental | Not described Receives: Device: Electrocardiogram recording |
| Normal Sinus Rhythm | Experimental | Not described Receives: Device: Electrocardiogram recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary outcomes
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 SUT, compared to the reference 12-lead ECG.
Measured: 4 months
Co-primary outcomes
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 SUT, compared to the reference 12-lead ECG.
Measured: 4 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. 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: 4 months
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. For each type of wave (P, QRS and T),
Measured: 4 months
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 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: 4 months
Heart Rate equivalence
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 reference ECG
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Jul 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
- Investigators
- Jeffrey Wessler, MD, Principal investigator, Heartbeat Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316337
- Sponsor's protocol ID
- WBS08-ECG
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2022
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05316337
- Acronym / sponsor ID
- WBS08-ECG
- Conditions
- Atrial Fibrillation
- Keywords
- mHealth, Atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Apr 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 evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | Experimental | Device: Electrocardiogram recording |
| Normal Sinus Rhythm | Experimental | Device: Electrocardiogram recording |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not 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 (18 listed)
- Vulnerable subject with regard to regulations in force
- Subject who refused to participate in the study,
- Subject mentally impaired resulting in limited ability to cooperate
- Subject with electrical stimulation by pacemaker
- Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able to hold still (e.g Parkinson disease)
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 |
|---|---|---|
| Electrocardiogram recordingECG recording with investigational device | Device | Atrial fibrillation, Normal Sinus Rhythm |
| Electrocardiogram recordingECG recording with reference device | Device | Atrial fibrillation, Normal Sinus Rhythm |
Primary outcome
Co-primary outcomes
Time frame: 4 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 SUT, compared to the reference 12-lead ECG.
Co-primary outcomes
Time frame: 4 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 SUT, compared to the reference 12-lead ECG.
4 secondary outcomes
Evaluation of the classification into heart rate subgroups
Time frame: 4 months
Clinical Equivalence of ECG waveforms
Time frame: 4 months
Clinical Equivalence of ECG waveforms
Time frame: 4 months
Heart Rate equivalence
Time frame: 4 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 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.
Jeffrey Wessler, MD principal investigator
Heartbeat Health
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram recording in people with Atrial Fibrillation, run by Withings at 10 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 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 outcomes (time frame: 4 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 20 Mar 2024.