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/NCT06041373</url>
    </required_header>
    <id_info>
      <org_study_id>104343</org_study_id>
      <nct_id>NCT06041373</nct_id>
    </id_info>
    <brief_title>Verily Watch Cardio (AF and ECG) Study</brief_title>
    <official_title>Verily Watch Cardio (AF and ECG) Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Verily Life Sciences LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Verily Life Sciences LLC</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is designed to evaluate the performance of the Verily Watch Cardio for recording&#xD;
        electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial&#xD;
        fibrillation (AF) episodes, in a free-living environment, in participants at risk for having&#xD;
        an AF event.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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 suspected AF episode detection</measure>
      <time_frame>Up to 14 days</time_frame>
      <description>Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>A sensitivity analysis estimating the range of sensitivities and specificities</measure>
      <time_frame>Up to 14 days</time_frame>
      <description>A sensitivity analysis estimating the range of sensitivities and specificities observed when imputing missing test device data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and Specificity in defined subgroups</measure>
      <time_frame>Up to 14 days</time_frame>
      <description>Sensitivity and Specificity in subgroups defined by: race, age-groups, activity level, skin-tone and AF-burden</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)</measure>
      <time_frame>Up to 14 days</time_frame>
      <description>Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) based on recorded ECG data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant-level and heartbeat level sensitivity/specificity of P-wave detection</measure>
      <time_frame>Up to 14 days</time_frame>
      <description>Participant-level and heartbeat level sensitivity/specificity of P-wave detection based on recorded ECG data</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Paroxysmal Atrial Fibrillation Patients</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Verily Watch Cardio</intervention_name>
      <description>The Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses.</description>
      <arm_group_label>Paroxysmal Atrial Fibrillation Patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>iRhythm Zio monitor</intervention_name>
      <description>The iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days.</description>
      <arm_group_label>Paroxysmal Atrial Fibrillation Patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Schiller CARDIOVIT FT-1</intervention_name>
      <description>The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes.</description>
      <arm_group_label>Paroxysmal Atrial Fibrillation Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          At risk of having an AF event determined by a diagnosis of paroxysmal atrial fibrillation&#xD;
          (PAF)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 22 years old&#xD;
  &#xD;
            -  Able to read and speak English&#xD;
  &#xD;
            -  Participant understands the study requirements and is able and willing to sign written&#xD;
               Informed Consent&#xD;
  &#xD;
            -  At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF&#xD;
               (PAF) and meeting one or more of the following:&#xD;
  &#xD;
                 1. Scheduled or to be scheduled to undergo AF ablation&#xD;
  &#xD;
                 2. AF burden of ≥25% in the 3 months prior to consent date as confirmed via an&#xD;
                    implantable loop recorder (ILR), holter monitor, or adhesive monitoring patch&#xD;
  &#xD;
                 3. CHA2DS2VASc score ≥3&#xD;
  &#xD;
                 4. Left atrial diameter ≥4.4 cm as confirmed by transthoracic echo (TTE) within one&#xD;
                    year of consent&#xD;
  &#xD;
            -  Without significant limitation in ability to participate in the study, in the opinion&#xD;
               of the Investigator&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a pacemaker or implantable cardioverter defibrillator (ICD)&#xD;
  &#xD;
            -  Currently on class Ic or class III antiarrhythmic medication that has been successful&#xD;
               in eliminating AF (no documented AF of more than 30 seconds since the initiation of&#xD;
               the medication). Should be at least one week off medication.&#xD;
  &#xD;
            -  Had successful AF ablation (no documented AF of more than 30 seconds post procedure)&#xD;
  &#xD;
            -  Known severe allergy to nickel or metal jewelry&#xD;
  &#xD;
            -  Known allergic reaction to polyester, nylon, spandex, adhesives or hydrogels; or with&#xD;
               family history of adhesive skin allergies&#xD;
  &#xD;
            -  Are diagnosed with persistent AF&#xD;
  &#xD;
            -  Have an implantable neuro-stimulator&#xD;
  &#xD;
            -  Currently wearing an ECG patch that prevents the use of the FDA-cleared wearable ECG&#xD;
               patch, at the discretion of the Investigator.&#xD;
  &#xD;
            -  Have discolored wrists (e.g., tattoos, ink), at the discretion of the Investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Hamid Ghanbari, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Verily Life Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christine Gee</last_name>
      <phone>650-253-0000</phone>
      <email>christineshin@verily.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lubna Kazi</last_name>
      <phone>650-253-0000</phone>
      <email>lkazi@verily.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Colorado Heart and Vascular</name>
        <address>
          <city>Lakewood</city>
          <state>Colorado</state>
          <zip>80228</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Bailey</last_name>
        <phone>303-595-2619</phone>
        <email>dbailey@chvpc.com</email>
      </contact>
      <investigator>
        <last_name>Ganesh Venkataraman, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ascension Providence Hospital</name>
        <address>
          <city>Southfield</city>
          <state>Michigan</state>
          <zip>48075</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Candice Edillo</last_name>
        <phone>248-849-3197</phone>
        <email>candice.edillo@ascension.org</email>
      </contact>
      <investigator>
        <last_name>Christian Machado, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Wake Forest Medical Center</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Karen Blinson</last_name>
        <phone>336-716-5706</phone>
        <email>kblinson@wakehealth.edu</email>
      </contact>
      <investigator>
        <last_name>Ghanshyam Palamaner Subash Shantha, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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/NCT06041373
  org study id: 104343
  nct id: NCT06041373
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This study is designed to evaluate the performance of the Verily Watch Cardio for recording
        electrocardiogram (ECG) and photoplethysmography (PPG) signals and detecting suspected atrial
        fibrillation (AF) episodes, in a free-living environment, in participants at risk for having
        an AF event.
  observational model: Cohort
  time perspective: Prospective
  measure: Sensitivity and Specificity of suspected AF episode detection
  time frame: Up to 14 days
  description: Sensitivity and Specificity of suspected AF episode detection by the irregular pulse detection algorithm
  measure: A sensitivity analysis estimating the range of sensitivities and specificities
  time frame: Up to 14 days
  description: A sensitivity analysis estimating the range of sensitivities and specificities observed when imputing missing test device data
  measure: Sensitivity and Specificity in defined subgroups
  time frame: Up to 14 days
  description: Sensitivity and Specificity in subgroups defined by: race, age-groups, activity level, skin-tone and AF-burden
  measure: Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA)
  time frame: Up to 14 days
  description: Mean difference in Interbeat interval (IBI) and the associated limits of agreement (LoA) based on recorded ECG data
  measure: Participant-level and heartbeat level sensitivity/specificity of P-wave detection
  time frame: Up to 14 days
  description: Participant-level and heartbeat level sensitivity/specificity of P-wave detection based on recorded ECG data
  arm group label: Paroxysmal Atrial Fibrillation Patients
  intervention type: Device
  intervention name: Verily Watch Cardio
  description: The Verily Watch Cardio is an investigational wrist-worn wearable device containing multiple sensors to measure physiological and environmental metrics, including electrodes that enable a single-lead electrocardiogram (ECG) measurement and a photoplethysmogram (PPG) sensor to monitor for irregular pulses.
  arm group label: Paroxysmal Atrial Fibrillation Patients
  intervention type: Device
  intervention name: iRhythm Zio monitor
  description: The iRhythm Zio monitor, the reference device, is an FDA-cleared single-patient use, continuously recording ECG monitor that can be worn for up to 14 days.
  arm group label: Paroxysmal Atrial Fibrillation Patients
  intervention type: Device
  intervention name: Schiller CARDIOVIT FT-1
  description: The Schiller CARDIOVIT FT-1, the reference device, is an FDA-cleared portable 12-lead ECG machine capable of recording continuous standard 12-lead resting ECG for up to 4 minutes.
  arm group label: Paroxysmal Atrial Fibrillation Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  last name: Hamid Ghanbari, MD
  role: Principal Investigator
  affiliation: Verily Life Sciences
  last name: Christine Gee
  phone: 650-253-0000
  email: christineshin@verily.com
  last name: Lubna Kazi
  phone: 650-253-0000
  email: lkazi@verily.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation