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Validation Study of an Advanced Blood Pressure Monitor (TALISMAN)

Primary Purpose

Atrial Fibrillation, Hypertension, Valvular Heart Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BP measurement
AF detection
VHD detection
Sponsored by
Withings
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring blood pressure, Arrhythmias, Cardiac, atrial fibrillation, valvular disease, blood pressure monitors, electrocardiography, Doppler echocardiography, Heart diseases, Cardiovascular diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Clinique AXIUM Centre de cardiologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Blood pressure (BP)

Atrial fibrillation (AF)

Valvular heart disease (VHD)

Arm Description

Group for the validation of blood pressure measurement by the device

Group for the validation of detection of AF by the device

Group for the validation of detection of VHD by the device

Outcomes

Primary Outcome Measures

BP precision and accuracy
mean error and standard deviation on measurements, and standard deviation on patients (criteria 1 and 2 of ANSI/AAMI/ISO 81060-2:2013) against sphygmomanometer dual observer auscultation
AF and SR classification accuracy
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
VHD detection accuracy
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram

Secondary Outcome Measures

safety evaluation
frequency of adverse events

Full Information

First Posted
July 19, 2019
Last Updated
August 2, 2019
Sponsor
Withings
Collaborators
Clinact
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1. Study Identification

Unique Protocol Identification Number
NCT04030494
Brief Title
Validation Study of an Advanced Blood Pressure Monitor
Acronym
TALISMAN
Official Title
Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
June 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Withings
Collaborators
Clinact

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Hypertension, Valvular Heart Disease
Keywords
blood pressure, Arrhythmias, Cardiac, atrial fibrillation, valvular disease, blood pressure monitors, electrocardiography, Doppler echocardiography, Heart diseases, Cardiovascular diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood pressure (BP)
Arm Type
Other
Arm Description
Group for the validation of blood pressure measurement by the device
Arm Title
Atrial fibrillation (AF)
Arm Type
Other
Arm Description
Group for the validation of detection of AF by the device
Arm Title
Valvular heart disease (VHD)
Arm Type
Other
Arm Description
Group for the validation of detection of VHD by the device
Intervention Type
Diagnostic Test
Intervention Name(s)
BP measurement
Intervention Description
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
Intervention Type
Diagnostic Test
Intervention Name(s)
AF detection
Intervention Description
single lead ECG with Withings WPM04 and 12 lead ECG
Intervention Type
Diagnostic Test
Intervention Name(s)
VHD detection
Intervention Description
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Primary Outcome Measure Information:
Title
BP precision and accuracy
Description
mean error and standard deviation on measurements, and standard deviation on patients (criteria 1 and 2 of ANSI/AAMI/ISO 81060-2:2013) against sphygmomanometer dual observer auscultation
Time Frame
1 visit (45 minutes)
Title
AF and SR classification accuracy
Description
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
Time Frame
1 visit (30 minutes)
Title
VHD detection accuracy
Description
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
Time Frame
1 visit (30 minutes)
Secondary Outcome Measure Information:
Title
safety evaluation
Description
frequency of adverse events
Time Frame
1 visit (1 hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Clinique AXIUM Centre de cardiologie
City
Aix-en-Provence
ZIP/Postal Code
13090
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Validation Study of an Advanced Blood Pressure Monitor

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