xml: <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/NCT06023290</url>
    </required_header>
    <id_info>
      <org_study_id>Z-2023023</org_study_id>
      <nct_id>NCT06023290</nct_id>
    </id_info>
    <brief_title>Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation</brief_title>
    <acronym>VALIDATION</acronym>
    <official_title>Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ziekenhuis Oost-Limburg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ziekenhuis Oost-Limburg</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart&#xD;
        rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection&#xD;
        of atrial fibrillation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 3, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
      <description>Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Specificity</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
      <description>Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Accuracy</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
      <description>Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cramer's V</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
      <description>The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Positive predictive value</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient preference score (for the use of the diagnostic devices)</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
      <description>This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis</measure>
      <time_frame>During the heart rhythm measurements</time_frame>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Study population (single arm)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Heart rhythm measurements with Preventicus®</intervention_name>
      <description>The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.</description>
      <arm_group_label>Study population (single arm)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Heart rhythm measurements with FibriCheck®</intervention_name>
      <description>The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.</description>
      <arm_group_label>Study population (single arm)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Heart rhythm measurements with Apple Watch®</intervention_name>
      <description>The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.</description>
      <arm_group_label>Study population (single arm)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Heart rhythm measurements with 6L Kardia Mobile®</intervention_name>
      <description>The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.</description>
      <arm_group_label>Study population (single arm)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient is an ambulatory cardiology patient.&#xD;
  &#xD;
            -  The patient is at least 18 years old.&#xD;
  &#xD;
            -  The patient is sinus or in atrial fibrillation.&#xD;
  &#xD;
            -  The patient is able to perform the study procedures together with the study assistant.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a pacemaker&#xD;
  &#xD;
            -  Inclusion in another clinical trial that may influence the results of this trial&#xD;
  &#xD;
            -  The patient is unable to comprehend the informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Henri M.P.B.C. Gruwez, MD</last_name>
      <phone>+32475223949</phone>
      <email>henri.gruwez@zol.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ziekenhuis Oost-Limburg</name>
        <address>
          <city>Genk</city>
          <state>Limburg</state>
          <zip>3600</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Henri Gruwez, MD</last_name>
        <phone>+32475223949</phone>
        <email>henri.gruwez@zol.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023290
  org study id: Z-2023023
  nct id: NCT06023290
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart
        rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection
        of atrial fibrillation.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity
  time frame: During the heart rhythm measurements
  description: Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.
  measure: Specificity
  time frame: During the heart rhythm measurements
  description: Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.
  measure: Accuracy
  time frame: During the heart rhythm measurements
  description: Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
  measure: Cramer's V
  time frame: During the heart rhythm measurements
  description: The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.
  measure: Positive predictive value
  time frame: During the heart rhythm measurements
  measure: Patient preference score (for the use of the diagnostic devices)
  time frame: During the heart rhythm measurements
  description: This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.
  measure: Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis
  time frame: During the heart rhythm measurements
  arm group label: Study population (single arm)
  arm group type: Other
  intervention type: Diagnostic Test
  intervention name: Heart rhythm measurements with Preventicus®
  description: The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
  arm group label: Study population (single arm)
  intervention type: Diagnostic Test
  intervention name: Heart rhythm measurements with FibriCheck®
  description: The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
  arm group label: Study population (single arm)
  intervention type: Diagnostic Test
  intervention name: Heart rhythm measurements with Apple Watch®
  description: The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
  arm group label: Study population (single arm)
  intervention type: Diagnostic Test
  intervention name: Heart rhythm measurements with 6L Kardia Mobile®
  description: The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.
  arm group label: Study population (single arm)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Henri M.P.B.C. Gruwez, MD
  phone: +32475223949
  email: henri.gruwez@zol.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation