Atrial FibrillationMOVE-ECGNCT04041466
Validation Study of a Watch for the Detection of Atrial Fibrillation
A study testing AF detection by ECG in people with Atrial Fibrillation and Arrythmia, Cardiac, run by Withings at 2 sites in France.
Trial summary
The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrythmia, Cardiac
- What is being tested?
- AF detection by ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Jun 2019to 12 Jul 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults, men or women, at least 18 years old
- person having signed the informed consent form
- person affiliated to a social security system
Who cannot join
- vulnerable subject according to current regulation:
- pregnant woman, parturient or breastfeeding
- subject deprived of freedom by judicial, medical or administrative decision
- subject legally protected or unable to express his consent
- subject non-beneficiary of healthcare
- subject falling into more than one of the above categories
Show all 10Show fewer
- subject who refused to participate in the study
- subject in linguistic or psychic incapacity to sign a written informed consent form
- subject in physical incapacity to wear a watch on their wrist
- subject with electrical stimulation by pacemaker
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, 13090
Centre Cardiologique du Nord
Saint-Denis, 93200
About this study
Official title: Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation
The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Arrythmia, Cardiac
- Being tested
- AF detection by ECG
- Keywords
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular diseases, Heart diseases, Wearable Electronic Devices, Electrocardiography
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF detection by ECGDiagnostic test
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation (AF) | Experimental | Patients diagnosed with AF during reference ECG Receives: Diagnostic Test: AF detection by ECG |
| Sinus Rhythm (SR) | Experimental | Patients diagnosed with SR during reference ECG Receives: Diagnostic Test: AF detection by ECG |
| Other Arrythmia | Experimental | Patients diagnosed with an arrhythmia other than AF during the reference ECG Receives: Diagnostic Test: AF detection by ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF and SR classification accuracy
sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG
Measured: 1 visit (30 minutes)
Secondary outcomes (2)
Quality of the 1-lead ECG strips
sensitivity and specificity of detection of AF and SR from 1-lead ECG strips reviewed by a blind, trained cardiologist against reference 12-lead ECG
Measured: 1 visit (30 minutes)
safety evaluation
frequency of adverse events
Measured: 1 visit (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start7 Jun 2019
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041466
- Sponsor's protocol ID
- 2019-A00721-56
- Acronym
- MOVE-ECG
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 5 Aug 2019
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04041466
- Acronym / sponsor ID
- MOVE-ECG / 2019-A00721-56
- Conditions
- Atrial Fibrillation, Arrythmia, Cardiac
- Keywords
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular diseases, Heart diseases, Wearable Electronic Devices, Electrocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 1 Aug 2019 (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 proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation (AF) | Experimental | Diagnostic Test: AF detection by ECGPatients diagnosed with AF during reference ECG |
| Sinus Rhythm (SR) | Experimental | Diagnostic Test: AF detection by ECGPatients diagnosed with SR during reference ECG |
| Other Arrythmia | Experimental | Diagnostic Test: AF detection by ECGPatients diagnosed with an arrhythmia other than AF during the reference ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults, men or women, at least 18 years old
- person having signed the informed consent form
- person affiliated to a social security system
Key exclusion criteria (10 listed)
- vulnerable subject according to current regulation:
- subject who refused to participate in the study
- subject in linguistic or psychic incapacity to sign a written informed consent form
- subject in physical incapacity to wear a watch on their wrist
- subject with electrical stimulation by pacemaker
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 |
|---|---|---|
| AF detection by ECGSingle-lead ECG with Withings watch HWA08 and reference 12-lead ECG | Diagnostic test | Atrial fibrillation (AF), Other Arrythmia, Sinus Rhythm (SR) |
Primary outcome
AF and SR classification accuracy
Time frame: 1 visit (30 minutes)
sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG
2 secondary outcomes
Quality of the 1-lead ECG strips
Time frame: 1 visit (30 minutes)
safety evaluation
Time frame: 1 visit (30 minutes)
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 5 Aug 2019.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF detection by ECG in people with Atrial Fibrillation and Arrythmia, Cardiac, run by Withings at 2 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 3 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: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
AF and SR classification accuracy (time frame: 1 visit (30 minutes)). 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 5 Aug 2019.