Status:
COMPLETED
Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation
Lead Sponsor:
Withings
Conditions:
Atrial Fibrillation
Arrythmia, Cardiac
Eligibility:
All Genders
18+ years
Brief Summary
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the ECG-SW1 software and the PPG-SW1 software integrated into the HWA09 watch developed by With...
Detailed Description
HWA09 is a wrist-worn watch that enables to record a single-lead ECG similar to the standard lead I configuration, and a photoplethysmogram (PPG). Primary objective : To validate the diagnostic perf...
Eligibility Criteria
Inclusion
- Individuals over 18yo
- Individuals who expressed their non-opposition to take part in the study
- Individuals affiliated to a social security system or eligible
Exclusion
- Vulnerable individuals according to the regulation in force :
- Pregnant, parturient or breastfeeding women
- Individuals deprived of liberty by a court, medical or administrative order
- Individuals under 18yo
- Individuals legally protected or unable to express their non-opposition to take part in
- Individuals unaffiliated to or not beneficiary of a social security system
- Individuals who fit in multiple categories above
- Individuals having refused to take part in the study
- Individuals linguistically or mentally unable to express their non-opposition
- Individuals physically unable to wear a watch
- Individuals with an electrical pacing by a pacemaker
Key Trial Info
Start Date :
December 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT04351386
Start Date
December 20 2019
End Date
April 7 2021
Last Update
November 16 2021
Active Locations (3)
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1
Institut Cœur Paris Centre Turin
Paris, Île-de-France Region, France, 75008
2
Hopital Europeen Georges Pompidou
Paris, Île-de-France Region, France, 75015
3
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, France, 93200