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出境医 / 临床实验 / Validation Study of an Advanced Blood Pressure Monitor (TALISMAN)

Validation Study of an Advanced Blood Pressure Monitor (TALISMAN)

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Hypertension Valvular Heart Disease Diagnostic Test: BP measurement Diagnostic Test: AF detection Diagnostic Test: VHD detection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 13, 2019
Actual Primary Completion Date : June 13, 2019
Actual Study Completion Date : June 13, 2019
Arms and Interventions
Arm Intervention/treatment
Blood pressure (BP)
Group for the validation of blood pressure measurement by the device
 Diagnostic Test: BP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation

Diagnostic Test: 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
 Diagnostic Test: AF detection
single lead ECG with Withings WPM04 and 12 lead ECG

Diagnostic Test: 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
 Diagnostic Test: BP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation

Diagnostic Test: AF detection
single lead ECG with Withings WPM04 and 12 lead ECG

Diagnostic Test: VHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Outcome Measures
Primary Outcome Measures :
  1. BP precision and accuracy [ Time Frame: 1 visit (45 minutes) ]
    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

  2. AF and SR classification accuracy [ Time Frame: 1 visit (30 minutes) ]
    sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG

  3. VHD detection accuracy [ Time Frame: 1 visit (30 minutes) ]
    sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram


Secondary Outcome Measures :
  1. safety evaluation [ Time Frame: 1 visit (1 hour) ]
    frequency of adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Locations
Layout table for location information
France
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, France, 13090
Sponsors and Collaborators
Withings
Clinact
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE March 13, 2019
Actual Primary Completion Date June 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • BP precision and accuracy [ Time Frame: 1 visit (45 minutes) ]
    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 [ Time Frame: 1 visit (30 minutes) ]
    sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
  • VHD detection accuracy [ Time Frame: 1 visit (30 minutes) ]
    sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		safety evaluation [ Time Frame: 1 visit (1 hour) ]
frequency of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation Study of an Advanced Blood Pressure Monitor
Official Title  ICMJE Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Atrial Fibrillation
  • Hypertension
  • Valvular Heart Disease
Intervention  ICMJE
  • Diagnostic Test: BP measurement
    sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
  • Diagnostic Test: AF detection
    single lead ECG with Withings WPM04 and 12 lead ECG
  • Diagnostic Test: VHD detection
    phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Study Arms  ICMJE
  • Blood pressure (BP)
    Group for the validation of blood pressure measurement by the device
    Interventions:
    • Diagnostic Test: BP measurement
    • Diagnostic Test: VHD detection
  • Atrial fibrillation (AF)
    Group for the validation of detection of AF by the device
    Interventions:
    • Diagnostic Test: AF detection
    • Diagnostic Test: VHD detection
  • Valvular heart disease (VHD)
    Group for the validation of detection of VHD by the device
    Interventions:
    • Diagnostic Test: BP measurement
    • Diagnostic Test: AF detection
    • Diagnostic Test: VHD detection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2019) 		218
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 13, 2019
Actual Primary Completion Date June 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04030494
Other Study ID Numbers  ICMJE 2018-A02847-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Withings
Study Sponsor  ICMJE Withings
Collaborators  ICMJE Clinact
Investigators  ICMJE Not Provided
PRS Account Withings
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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