Validation Study of an Advanced Blood Pressure Monitor (TALISMAN)

Withings

Status: Completed

Conditions: Hypertension; Atrial Fibrillation; Valvular Heart Disease

Treatments: Diagnostic Test: BP measurement; Diagnostic Test: VHD detection; Diagnostic Test: AF detection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04030494

2018-A02847-48

Details and patient eligibility

About

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 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female over 18 years old,
• Subject who signed the consent form,
• Subject affiliated to a social security scheme or entitled.

Exclusion criteria

• 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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 3 patient groups

Blood pressure (BP)

Other group

Description:

Group for the validation of blood pressure measurement by the device

Treatment:

Diagnostic Test: BP measurement

Diagnostic Test: VHD detection

Atrial fibrillation (AF)

Other group

Description:

Group for the validation of detection of AF by the device

Treatment:

Diagnostic Test: VHD detection

Diagnostic Test: AF detection

Valvular heart disease (VHD)

Other group

Description:

Group for the validation of detection of VHD by the device

Treatment:

Diagnostic Test: BP measurement

Diagnostic Test: VHD detection

Diagnostic Test: AF detection