Validation Study of a Watch for the Detection of Atrial Fibrillation
NCT ID: NCT04041466
Last Updated: 2019-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2019-06-07
2019-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Sinus Rhythm (SR)
Patients diagnosed with SR during reference ECG
AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Other Arrythmia
Patients diagnosed with an arrhythmia other than AF during the reference ECG
AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Interventions
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AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Eligibility Criteria
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Inclusion Criteria
* person having signed the informed consent form
* person affiliated to a social security system
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Clinact
OTHER
Withings
INDUSTRY
Responsible Party
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Locations
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Clinique AXIUM Centre de cardiologie
Aix-en-Provence, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Countries
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Other Identifiers
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2019-A00721-56
Identifier Type: -
Identifier Source: org_study_id
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