Status:
COMPLETED
Validation Study of a Watch for the Detection of Atrial Fibrillation
Lead Sponsor:
Withings
Collaborating Sponsors:
Clinact
Conditions:
Atrial Fibrillation
Arrythmia, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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).
Eligibility Criteria
Inclusion
- adults, men or women, at least 18 years old
- person having signed the informed consent form
- person affiliated to a social security system
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04041466
Start Date
June 7 2019
End Date
July 12 2019
Last Update
August 5 2019
Active Locations (2)
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1
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, France, 13090
2
Centre Cardiologique du Nord
Saint-Denis, France, 93200