Atrial FibrillationTALISMANNCT04030494
Validation Study of an Advanced Blood Pressure Monitor
A study testing BP measurement, AF detection and VHD detection in people with Atrial Fibrillation and Hypertension, run by Withings at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- What is being tested?
- BP measurement, AF detection and VHD detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2019to 13 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years old,
- Subject who signed the consent form,
- Subject affiliated to a social security scheme or entitled.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Being tested
- BP measurement, AF detection, VHD detection
- Keywords
- blood pressure, Arrhythmias, Cardiac, atrial fibrillation, valvular disease, blood pressure monitors, electrocardiography, Doppler echocardiography, Heart diseases, Cardiovascular diseases
- Medical subject headings
- Atrial Fibrillation, Hypertension, Heart Valve Diseases, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP measurementDiagnostic test
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
AF detectionDiagnostic test
single lead ECG with Withings WPM04 and 12 lead ECG
VHD detectionDiagnostic test
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure (BP) | Other | Group for the validation of blood pressure measurement by the device Receives: Diagnostic Test: BP measurement; Diagnostic Test: VHD detection |
| Atrial fibrillation (AF) | Other | Group for the validation of detection of AF by the device Receives: Diagnostic Test: AF detection; Diagnostic Test: VHD detection |
| Valvular heart disease (VHD) | Other | Group for the validation of detection of VHD by the device Receives: Diagnostic Test: BP measurement; Diagnostic Test: AF detection; Diagnostic Test: VHD detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 visit (45 minutes)
AF and SR classification accuracy
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
Measured: 1 visit (30 minutes)
VHD detection accuracy
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
Measured: 1 visit (30 minutes)
Secondary outcomes (1)
safety evaluation
frequency of adverse events
Measured: 1 visit (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start13 Mar 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030494
- Sponsor's protocol ID
- 2018-A02847-48
- Acronym
- TALISMAN
- Status last verified
- Aug 2019
- First submitted
- 19 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04030494
- Acronym / sponsor ID
- TALISMAN / 2018-A02847-48
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Keywords
- blood pressure, Arrhythmias, Cardiac, atrial fibrillation, valvular disease, blood pressure monitors, electrocardiography, Doppler echocardiography, Heart diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood pressure (BP) | Other | Diagnostic Test: BP measurement, Diagnostic Test: VHD detectionGroup for the validation of blood pressure measurement by the device |
| Atrial fibrillation (AF) | Other | Diagnostic Test: AF detection, Diagnostic Test: VHD detectionGroup for the validation of detection of AF by the device |
| Valvular heart disease (VHD) | Other | Diagnostic Test: BP measurement, Diagnostic Test: AF detection, Diagnostic Test: VHD detectionGroup for the validation of detection of VHD by the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female over 18 years old,
- Subject who signed the consent form,
- Subject affiliated to a social security scheme or entitled.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP measurementsequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation | Diagnostic test | Blood pressure (BP), Valvular heart disease (VHD) |
| AF detectionsingle lead ECG with Withings WPM04 and 12 lead ECG | Diagnostic test | Atrial fibrillation (AF), Valvular heart disease (VHD) |
| VHD detectionphonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography | Diagnostic test | Atrial fibrillation (AF), Blood pressure (BP), Valvular heart disease (VHD) |
Primary outcome
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
1 secondary outcome
safety evaluation
Time frame: 1 visit (1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BP measurement, AF detection and VHD detection in people with Atrial Fibrillation and Hypertension, run by Withings at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BP precision and accuracy (time frame: 1 visit (45 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.