<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464499</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A03346-51</org_study_id>
    <nct_id>NCT04464499</nct_id>
  </id_info>
  <brief_title>Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation</brief_title>
  <acronym>Core AF</acronym>
  <official_title>Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Withings</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Withings</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed clinical study aims to validate the diagnostic performance, compared to a&#xD;
      reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for&#xD;
      the automatic identification of atrial fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BPM Core is a blood-pressure monitor with an build-in single-channel electrocardiogram&#xD;
      similar to a lead I.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      The primary objective is to demonstrate that Withings BPM Core has acceptable sensitivity and&#xD;
      specificity in the automatic identification of AF and SR in comparison with a gold-standard&#xD;
      diagnosis from a 12-lead ECG by board certified cardiologists.&#xD;
&#xD;
      The algorithm classifies the device signals into four categories: normal sinus rhythm (RSN),&#xD;
      AF, arrhythmia other than AF, or non-interpretable. The latter category includes signals of&#xD;
      insufficient quality to be interpreted with confidence.&#xD;
&#xD;
      This classification will be compared to the diagnosis made by three independent, blinded&#xD;
      cardiologists based on a 12-lead ECG. The final diagnosis retained will be decided by&#xD;
      majority with adjudication by a consensus of 3 to 6 cardiologists. The sensitivity and&#xD;
      specificity of the device will then be estimated.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      The first secondary objective is to assess the quality of tracings of the BPM Core armband&#xD;
      thanks to a qualitative and quantitative comparison between BPM Core tracings and reference&#xD;
      ECG ones, based on clinical evaluation criteria.&#xD;
&#xD;
      Firstly, three independent cardiologists who have not performed or read the reference ECG and&#xD;
      do not know the patient's clinical files will make a diagnosis from the recordings from the&#xD;
      BPM Core. There will be a majority vote to select the diagnosis. The cases where the three&#xD;
      readers reached three different diagnosis will be reviewed by a panel of 3 to 6 board&#xD;
      certified cardiologists who will decide by consensus. Sensitivity and specificity will be&#xD;
      calculated relative to the reference ECG.&#xD;
&#xD;
      Secondly, quantitative analyses will be performed to assess the quality of ECG tracings&#xD;
      provided by Withings BPM Core and its software, as follows:&#xD;
&#xD;
        -  The visibility and polarity of the ECG waves (namely P-waves, QRS complexes and T-waves)&#xD;
           will be determined by the cardiologists for each lead I signals recorded with Withings&#xD;
           BPM Core and with the 12-channel ECG device. The assessment will be made on the 5th&#xD;
           complete beat of the recording. For each of the waves (P, QRS and T), the agreement of&#xD;
           visibility and the agreement of polarity (when both are visible) between the signals of&#xD;
           Withings BPM Core and the reference ECG device will be computed.&#xD;
&#xD;
        -  The duration of the main ECG intervals (namely QT interval, QRS width and PR interval)&#xD;
           will be determined by the cardiologists for each lead I signal recorded by Withings BPM&#xD;
           Core and the 12-channel ECG device. The measurement will be made with a caliper on the&#xD;
           5th complete beat of the recording. For each interval (QT, QRS, PR), the difference of&#xD;
           length between the signals of Withings BPM Core and the reference ECG device will be&#xD;
           computed.&#xD;
&#xD;
        -  The heart rate will be first determined by the cardiologists for each lead I signal&#xD;
           (recorded by Withings BPM Core and the 12-channel ECG device) which are diagnosed as&#xD;
           NSR. The heart rate difference between the signals of Withings BPM Core and the&#xD;
           reference ECG device will be computed. Second, the heart rate of the signals recorded&#xD;
           with the BPM Core will be computed by the Withings software. The difference between the&#xD;
           heart rate estimated by Withings software on Withings BPM Core signals and the heart&#xD;
           rate determined by the cardiologists on the lead I signal from the ECG reference device&#xD;
           will also be calculated.&#xD;
&#xD;
      The sponsor will make sure that the same cardiologist will not be asked to annotate both a&#xD;
      Withings BPM Core signal and the corresponding lead I signal from the 12-channel ECG device.&#xD;
      The sponsor will then centralize the annotations of Withings BPM Core tracings and of the ECG&#xD;
      reference lead I signals and perform agreement calculations on synchronous pairs.&#xD;
&#xD;
      The second secondary objective is to verify the safety of use of the device by analyzing&#xD;
      adverse effects.&#xD;
&#xD;
      The safety of use of the device will be assessed by the number of adverse effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG</measure>
    <time_frame>1 year</time_frame>
    <description>sensitivity from the 2x2 confusion matrix AF vs 'non-AF'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG</measure>
    <time_frame>1 year</time_frame>
    <description>sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the cardiologists' classification in AF from the BPM Core ECG</measure>
    <time_frame>1 year</time_frame>
    <description>sensitivity from the 2x2 confusion matrix AF vs 'non-AF'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the cardiologists' classification in SR from the BPM Core ECG</measure>
    <time_frame>1 year</time_frame>
    <description>sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the visibility of P-waves of single-lead ECG from BPM Core</measure>
    <time_frame>1 year</time_frame>
    <description>(true positives + true negatives)/(sample size) from the 2x2 confusion matrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the positivity of P-waves of single-lead ECG from BPM Core</measure>
    <time_frame>1 year</time_frame>
    <description>(true positives + true negatives)/(sample size) from the 2x2 confusion matrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the visibility of QRS-complexes of single-lead ECG from BPM Core</measure>
    <time_frame>1 year</time_frame>
    <description>(true positives + true negatives)/(sample size) from the 2x2 confusion matrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the positivity of QRS-complexes of single-lead ECG from BPM Core</measure>
    <time_frame>1 year</time_frame>
    <description>(true positives + true negatives)/(sample size) from the 2x2 confusion matrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the visibility of T-waves of single-lead ECG from BPM Core</measure>
    <time_frame>1 year</time_frame>
    <description>(true positives + true negatives)/(sample size) from the 2x2 confusion matrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the positivity of T-waves of single-lead ECG from BPM Core</measure>
    <time_frame>1 year</time_frame>
    <description>(true positives + true negatives)/(sample size) from the 2x2 confusion matrix</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Arrhythmias, Cardiac</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>atrial fibrillation (AF)</arm_group_label>
    <description>Patients diagnosed with AF during reference ECG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sinus rhythm (SR)</arm_group_label>
    <description>Patients diagnosed with SR during reference ECG</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ECG measurement</intervention_name>
    <description>Simultaneous recording of a single-lead ECG signal with the Withings BPM Core and ECG signal for the reference 12-lead ECG</description>
    <arm_group_label>atrial fibrillation (AF)</arm_group_label>
    <arm_group_label>sinus rhythm (SR)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        in and out patients from cardiology services&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female who are 18 years or older&#xD;
&#xD;
          -  Subject who signed the written informed consent form,&#xD;
&#xD;
          -  Able to communicate effectively with and follow instructions from the study staff&#xD;
&#xD;
          -  Person with an arm circumference between 22 and 42 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable subject with regard to regulations&#xD;
&#xD;
               -  Pregnant, parturient or breastfeeding woman,&#xD;
&#xD;
               -  Subject who is deprived of liberty by judicial, medical or administrative&#xD;
                  decision,&#xD;
&#xD;
               -  Underage subject,&#xD;
&#xD;
               -  Legally protected subject, or subject who is unable to sign the written informed&#xD;
                  consent form,&#xD;
&#xD;
               -  Subject who is not beneficiary or not affiliated to a social security scheme,&#xD;
&#xD;
               -  Subject within several of the above categories,&#xD;
&#xD;
          -  Subject who refused to participate in the study,&#xD;
&#xD;
          -  Subject in linguistic or psychic incapacity to sign a written informed consent form,&#xD;
&#xD;
          -  Subject in physical incapacity to wear a blood pressure monitor&#xD;
&#xD;
          -  Subject with electrical stimulation by pacemaker&#xD;
&#xD;
          -  Significant tremor that prevents subject from being able to hold still&#xD;
&#xD;
          -  Known sensitivity to medical adhesives, isopropyl alcohol, or ECG electrodes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Campo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Withings</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Campo, PhD</last_name>
    <phone>+33 1 41 46 04 60</phone>
    <email>david.campo@withings.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David Campo, MD</last_name>
    <email>fouassier@icpc.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ICPC Floréale</name>
      <address>
        <city>Bagnolet</city>
        <zip>93170</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrien Pasteur-Rousseau, MD</last_name>
      <email>adrien.pasteur@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ICPC Turin</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Fouassier, MD</last_name>
      <email>fouassier@icpc.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>arrhythmia, cardiac</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>heart disease</keyword>
  <keyword>wearable electronic device</keyword>
  <keyword>ECG</keyword>
  <keyword>blood pressure monitor</keyword>
  <keyword>electrocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual patient data (IPD) are considered as confidential in this study. After the end the final quality control, the database will be frozen and all the IPD will be archived.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464499
org study id: 2019-A03346-51
nct id: NCT04464499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed clinical study aims to validate the diagnostic performance, compared to a
      reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for
      the automatic identification of atrial fibrillation (AF).
BPM Core is a blood-pressure monitor with an build-in single-channel electrocardiogram
      similar to a lead I.

      Primary objective:

      The primary objective is to demonstrate that Withings BPM Core has acceptable sensitivity and
      specificity in the automatic identification of AF and SR in comparison with a gold-standard
      diagnosis from a 12-lead ECG by board certified cardiologists.

      The algorithm classifies the device signals into four categories: normal sinus rhythm (RSN),
      AF, arrhythmia other than AF, or non-interpretable. The latter category includes signals of
      insufficient quality to be interpreted with confidence.

      This classification will be compared to the diagnosis made by three independent, blinded
      cardiologists based on a 12-lead ECG. The final diagnosis retained will be decided by
      majority with adjudication by a consensus of 3 to 6 cardiologists. The sensitivity and
      specificity of the device will then be estimated.

      Secondary objectives:

      The first secondary objective is to assess the quality of tracings of the BPM Core armband
      thanks to a qualitative and quantitative comparison between BPM Core tracings and reference
      ECG ones, based on clinical evaluation criteria.

      Firstly, three independent cardiologists who have not performed or read the reference ECG and
      do not know the patient's clinical files will make a diagnosis from the recordings from the
      BPM Core. There will be a majority vote to select the diagnosis. The cases where the three
      readers reached three different diagnosis will be reviewed by a panel of 3 to 6 board
      certified cardiologists who will decide by consensus. Sensitivity and specificity will be
      calculated relative to the reference ECG.

      Secondly, quantitative analyses will be performed to assess the quality of ECG tracings
      provided by Withings BPM Core and its software, as follows:

        -  The visibility and polarity of the ECG waves (namely P-waves, QRS complexes and T-waves)
           will be determined by the cardiologists for each lead I signals recorded with Withings
           BPM Core and with the 12-channel ECG device. The assessment will be made on the 5th
           complete beat of the recording. For each of the waves (P, QRS and T), the agreement of
           visibility and the agreement of polarity (when both are visible) between the signals of
           Withings BPM Core and the reference ECG device will be computed.

        -  The duration of the main ECG intervals (namely QT interval, QRS width and PR interval)
           will be determined by the cardiologists for each lead I signal recorded by Withings BPM
           Core and the 12-channel ECG device. The measurement will be made with a caliper on the
           5th complete beat of the recording. For each interval (QT, QRS, PR), the difference of
           length between the signals of Withings BPM Core and the reference ECG device will be
           computed.

        -  The heart rate will be first determined by the cardiologists for each lead I signal
           (recorded by Withings BPM Core and the 12-channel ECG device) which are diagnosed as
           NSR. The heart rate difference between the signals of Withings BPM Core and the
           reference ECG device will be computed. Second, the heart rate of the signals recorded
           with the BPM Core will be computed by the Withings software. The difference between the
           heart rate estimated by Withings software on Withings BPM Core signals and the heart
           rate determined by the cardiologists on the lead I signal from the ECG reference device
           will also be calculated.

      The sponsor will make sure that the same cardiologist will not be asked to annotate both a
      Withings BPM Core signal and the corresponding lead I signal from the 12-channel ECG device.
      The sponsor will then centralize the annotations of Withings BPM Core tracings and of the ECG
      reference lead I signals and perform agreement calculations on synchronous pairs.

      The second secondary objective is to verify the safety of use of the device by analyzing
      adverse effects.

      The safety of use of the device will be assessed by the number of adverse effects.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG
time frame: 1 year
description: sensitivity from the 2x2 confusion matrix AF vs 'non-AF'
measure: Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG
time frame: 1 year
description: sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'
measure: Sensitivity of the cardiologists' classification in AF from the BPM Core ECG
time frame: 1 year
description: sensitivity from the 2x2 confusion matrix AF vs 'non-AF'
measure: Sensitivity of the cardiologists' classification in SR from the BPM Core ECG
time frame: 1 year
description: sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'
measure: Accuracy of the visibility of P-waves of single-lead ECG from BPM Core
time frame: 1 year
description: (true positives + true negatives)/(sample size) from the 2x2 confusion matrix
measure: Accuracy of the positivity of P-waves of single-lead ECG from BPM Core
time frame: 1 year
description: (true positives + true negatives)/(sample size) from the 2x2 confusion matrix
measure: Accuracy of the visibility of QRS-complexes of single-lead ECG from BPM Core
time frame: 1 year
description: (true positives + true negatives)/(sample size) from the 2x2 confusion matrix
measure: Accuracy of the positivity of QRS-complexes of single-lead ECG from BPM Core
time frame: 1 year
description: (true positives + true negatives)/(sample size) from the 2x2 confusion matrix
measure: Accuracy of the visibility of T-waves of single-lead ECG from BPM Core
time frame: 1 year
description: (true positives + true negatives)/(sample size) from the 2x2 confusion matrix
measure: Accuracy of the positivity of T-waves of single-lead ECG from BPM Core
time frame: 1 year
description: (true positives + true negatives)/(sample size) from the 2x2 confusion matrix
arm group label: atrial fibrillation (AF)
description: Patients diagnosed with AF during reference ECG
arm group label: sinus rhythm (SR)
description: Patients diagnosed with SR during reference ECG
intervention type: Diagnostic Test
intervention name: ECG measurement
description: Simultaneous recording of a single-lead ECG signal with the Withings BPM Core and ECG signal for the reference 12-lead ECG
arm group label: atrial fibrillation (AF)
arm group label: sinus rhythm (SR)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: David Campo, PhD
role: Study Director
affiliation: Withings
last name: David Campo, PhD
phone: +33 1 41 46 04 60
email: david.campo@withings.com
last name: David Campo, MD
email: fouassier@icpc.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Cardiovascular Diseases
mesh term: Arrhythmias, Cardiac
sharing ipd: No
ipd description: Individual patient data (IPD) are considered as confidential in this study. After the end the final quality control, the database will be frozen and all the IPD will be archived.