Status:
COMPLETED
Validation Study of an Advanced Blood Pressure Monitor
Lead Sponsor:
Withings
Collaborating Sponsors:
Clinact
Conditions:
Atrial Fibrillation
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders. The detection of cardiovasc...
Eligibility Criteria
Inclusion
- Male or female over 18 years old,
- Subject who signed the consent form,
- Subject affiliated to a social security scheme or entitled.
Exclusion
- Underage subject;
- Subject who refused to participate in the study;
- Subject participating in other research or clinical studies;
- Subject with body mass index greater than 35 kg/m2;
- Subject in linguistic or psychic incapacity to sign an informed consent;
- Subject with congenital cardiomyopathy;
- Subject with aorto-venous fistula;
- Subject with pulmonary pathology that may degrade the quality of the recording;
- Subject presenting a serious pathology compromising the realization of the examinations envisaged in the test;
- Subject with an arm injury incompatible with the use of an armband sphygmomanometer;
- Subject receiving an intravenous perfusion on the left arm;
- Subject with electrical stimulation by pacemaker, implantable cardioverter-defibrillator;
- Subject with prosthetic heart valve;
- Subject under kidney dialysis;
- Hemodynamically unstable subject (acute heart failure or cardiac assistance).
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2019
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04030494
Start Date
March 13 2019
End Date
June 13 2019
Last Update
August 5 2019
Active Locations (1)
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1
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, France, 13090