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
218 participants
INTERVENTIONAL
2019-03-13
2019-06-13
Brief Summary
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The detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.
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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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Blood pressure (BP)
Group for the validation of blood pressure measurement by the device
BP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
VHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Atrial fibrillation (AF)
Group for the validation of detection of AF by the device
AF detection
single lead ECG with Withings WPM04 and 12 lead ECG
VHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Valvular heart disease (VHD)
Group for the validation of detection of VHD by the device
BP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
AF detection
single lead ECG with Withings WPM04 and 12 lead ECG
VHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Interventions
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BP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
AF detection
single lead ECG with Withings WPM04 and 12 lead ECG
VHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Eligibility Criteria
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Inclusion Criteria
* Subject who signed the consent form,
* Subject affiliated to a social security scheme or entitled.
Exclusion Criteria
* 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).
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
Countries
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Other Identifiers
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2018-A02847-48
Identifier Type: -
Identifier Source: org_study_id
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