Status:
UNKNOWN
Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
Lead Sponsor:
Withings
Conditions:
Atrial Fibrillation
Arrhythmias, Cardiac
Eligibility:
All Genders
18-100 years
Brief Summary
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for the automatic ident...
Detailed Description
BPM Core is a blood-pressure monitor with an build-in single-channel electrocardiogram similar to a lead I. Primary objective: The primary objective is to demonstrate that Withings BPM Core has acce...
Eligibility Criteria
Inclusion
- male or female who are 18 years or older
- Subject who signed the written informed consent form,
- Able to communicate effectively with and follow instructions from the study staff
- Person with an arm circumference between 22 and 42 cm
Exclusion
- Vulnerable subject with regard to regulations
- Pregnant, parturient or breastfeeding woman,
- Subject who is deprived of liberty by judicial, medical or administrative decision,
- Underage subject,
- Legally protected subject, or subject who is unable to sign the written informed consent form,
- Subject who is not beneficiary or not affiliated to a social security scheme,
- Subject within several 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 blood pressure monitor
- Subject with electrical stimulation by pacemaker
- Significant tremor that prevents subject from being able to hold still
- Known sensitivity to medical adhesives, isopropyl alcohol, or ECG electrodes
Key Trial Info
Start Date :
July 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04464499
Start Date
July 6 2020
End Date
November 1 2020
Last Update
July 28 2020
Active Locations (2)
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1
ICPC Floréale
Bagnolet, France, 93170
2
ICPC Turin
Paris, France, 75004