<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/NCT04493749</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A013-58-49</org_study_id>
    <nct_id>NCT04493749</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection</brief_title>
  <acronym>ECG-SW1</acronym>
  <official_title>Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection</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>
      Withings Move ECG watch is designed to record ECG and detect automatically atrial&#xD;
      fibrillation. The aim of this study is to validate the performance of Move ECG watch to&#xD;
      detect atrial fibrillation compared to a reference 12-lead ECG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move&#xD;
      ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed&#xD;
      by independent cardiologists to assess&#xD;
&#xD;
        1. The presence or absence of atrial fibrillation&#xD;
&#xD;
        2. if waveforms of ECG recorded with Move ECG compared with the reference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2019</start_date>
  <completion_date type="Anticipated">October 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 15, 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 and Specificity of the automatic classification in AF by Move ECG 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>
  <secondary_outcome>
    <measure>Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG</measure>
    <time_frame>1 year</time_frame>
    <description>Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of use of Move ECG</measure>
    <time_frame>1 year</time_frame>
    <description>Frequency of adverse event appearance</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">234</enrollment>
  <condition>Atrial Fibrillation</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 Move ECG 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;
        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 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 physical incapacity to wear a wrist-worn watch&#xD;
&#xD;
          -  Subject with electrical stimulation by pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien Nahum</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Cardiologique du Nord</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Delphine Ladarré</last_name>
    <phone>+33 6 75 12 23 80</phone>
    <email>delphine.ladarre@withings.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rui Yi Yang</last_name>
    <phone>+33 6 19 78 25 54</phone>
    <email>ruiyi.yang@withings.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Cœur Paris Centre Turin</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75008</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Fouassier</last_name>
      <phone>+33 6 08 52 66 67</phone>
      <email>david.fouassier@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centre Cardiologique du Nord</name>
      <address>
        <city>Saint-Denis</city>
        <state>Ile-de-France</state>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 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 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04493749
org study id: 2019-A013-58-49
nct id: NCT04493749
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Withings Move ECG watch is designed to record ECG and detect automatically atrial
      fibrillation. The aim of this study is to validate the performance of Move ECG watch to
      detect atrial fibrillation compared to a reference 12-lead ECG.
Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move
      ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed
      by independent cardiologists to assess

        1. The presence or absence of atrial fibrillation

        2. if waveforms of ECG recorded with Move ECG compared with the reference.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG
time frame: 1 year
description: sensitivity from the 2x2 confusion matrix AF vs 'non-AF'
measure: Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG
time frame: 1 year
description: Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate
measure: Safety of use of Move ECG
time frame: 1 year
description: Frequency of adverse event appearance
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 Move ECG 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: N/A
healthy volunteers: No
last name: Julien Nahum
role: Principal Investigator
affiliation: Centre Cardiologique du Nord
last name: Delphine Ladarré
phone: +33 6 75 12 23 80
email: delphine.ladarre@withings.com
last name: Rui Yi Yang
phone: +33 6 19 78 25 54
email: ruiyi.yang@withings.com
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
country: France
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No