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/NCT06028893</url>
    </required_header>
    <id_info>
      <org_study_id>Z-2021058-2</org_study_id>
      <nct_id>NCT06028893</nct_id>
    </id_info>
    <brief_title>DIGITAL fOllow uP for aTrial fIbrillation After pulMonary veIn iSolaTion (DIGITAL OPTIMIST - 2)</brief_title>
    <official_title>A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation</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>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using&#xD;
        photoplethysmography (PPG) technology on a smartphone have been developed. This study&#xD;
        validates the performance of a digital health application (FibriCheck®) using PPG technology&#xD;
        on a smartphone against a single-lead ECG device (Kardia Mobile®).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 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>Two months</time_frame>
      <description>Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Specificity</measure>
      <time_frame>Two months</time_frame>
      <description>Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Accuracy</measure>
      <time_frame>Two months</time_frame>
      <description>Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Positive predictive value</measure>
      <time_frame>Two months</time_frame>
      <description>Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative predictive value</measure>
      <time_frame>Two months</time_frame>
      <description>Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity by heart rate interval</measure>
      <time_frame>Two months</time_frame>
      <description>Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Specificity by heart rate interval</measure>
      <time_frame>Two months</time_frame>
      <description>Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accuracy by heart rate interval</measure>
      <time_frame>Two months</time_frame>
      <description>Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of PPG measurements of insufficient quality for rhythm analysis</measure>
      <time_frame>Two months</time_frame>
      <description>PPG measurements by FibriCheck®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of ECG measurements of insufficient quality for rhythm analysis</measure>
      <time_frame>Two months</time_frame>
      <description>ECG measurements by Kardia Mobile®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval</measure>
      <time_frame>Two months</time_frame>
      <description>PPG measurements by FibriCheck®.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval</measure>
      <time_frame>Two months</time_frame>
      <description>ECG measurements by Kardia Mobile®.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All subjects will perform heart rhythm measurements with both diagnostic tests.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Heart rhythm measurements with FibriCheck®</intervention_name>
      <description>Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Heart rhythm measurements with Kardia Mobile®</intervention_name>
      <description>Measurements are performed immediately before and after every FibriCheck® measurement.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the&#xD;
               inclusion.&#xD;
  &#xD;
            -  Subject provides informed consent.&#xD;
  &#xD;
            -  Subject understands and agrees to comply with planned study procedures.&#xD;
  &#xD;
            -  Subject is able to perform measurements of the heart rhythm using the FibriCheck&#xD;
               application at home.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Insufficient cognitive or comprehensive level of Dutch to participate to the trial.&#xD;
  &#xD;
            -  No access to a smartphone or unable to perform FibriCheck measurements at home.&#xD;
  &#xD;
            -  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_contact>
      <last_name>Henri Gruwez, MD</last_name>
      <phone>+3289212051</phone>
      <email>henri.gruwez@zol.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laurent Pison, MD, PhD</last_name>
      <email>laurent.pison@zol.be</email>
    </overall_contact_backup>
    <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>+3289212051</phone>
        <email>henri.gruwez@zol.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Atrial Fibrillation</keyword>
    <keyword>Photoplethysmography</keyword>
    <keyword>Single-lead ECG</keyword>
    <keyword>Electrocardiogram</keyword>
    <keyword>Digital Health</keyword>
    <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>
  
  
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/NCT06028893
  org study id: Z-2021058-2
  nct id: NCT06028893
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using
        photoplethysmography (PPG) technology on a smartphone have been developed. This study
        validates the performance of a digital health application (FibriCheck®) using PPG technology
        on a smartphone against a single-lead ECG device (Kardia Mobile®).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity
  time frame: Two months
  description: Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
  measure: Specificity
  time frame: Two months
  description: Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
  measure: Accuracy
  time frame: Two months
  description: Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
  measure: Positive predictive value
  time frame: Two months
  description: Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.
  measure: Negative predictive value
  time frame: Two months
  description: Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.
  measure: Sensitivity by heart rate interval
  time frame: Two months
  description: Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
  measure: Specificity by heart rate interval
  time frame: Two months
  description: Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
  measure: Accuracy by heart rate interval
  time frame: Two months
  description: Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
  measure: Proportion of PPG measurements of insufficient quality for rhythm analysis
  time frame: Two months
  description: PPG measurements by FibriCheck®.
  measure: Proportion of ECG measurements of insufficient quality for rhythm analysis
  time frame: Two months
  description: ECG measurements by Kardia Mobile®.
  measure: Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
  time frame: Two months
  description: PPG measurements by FibriCheck®.
  measure: Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
  time frame: Two months
  description: ECG measurements by Kardia Mobile®.
  arm group label: Study group
  arm group type: Experimental
  description: All subjects will perform heart rhythm measurements with both diagnostic tests.
  intervention type: Diagnostic Test
  intervention name: Heart rhythm measurements with FibriCheck®
  description: Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
  arm group label: Study group
  intervention type: Diagnostic Test
  intervention name: Heart rhythm measurements with Kardia Mobile®
  description: Measurements are performed immediately before and after every FibriCheck® measurement.
  arm group label: Study group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Henri Gruwez, MD
  phone: +3289212051
  email: henri.gruwez@zol.be
  last name: Laurent Pison, MD, PhD
  email: laurent.pison@zol.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: No