<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/NCT04462653</url>
  </required_header>
  <id_info>
    <org_study_id>BZYL-5-1</org_study_id>
    <nct_id>NCT04462653</nct_id>
  </id_info>
  <brief_title>Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder</brief_title>
  <official_title>Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huami Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huami Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation&#xD;
      diagnosis between the Wearable Dynamic ECG Recorder and the Control device.&#xD;
&#xD;
      In this investigation, the following indicators is also evaluated:&#xD;
&#xD;
        1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation&#xD;
           compared with physician-adjudicated Gold Standard ECG recorder.&#xD;
&#xD;
        2. Waveform qualitative assessment&#xD;
&#xD;
        3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54&#xD;
           subjects with atrial fibrillation diagnosis in phase II) are enrolled in the&#xD;
           investigation according to the criteria.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 24, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consistent rate of atrial fibrillation diagnosis</measure>
    <time_frame>second 60</time_frame>
    <description>Electrical signals from ECG electrodes are collected with tested device and gold standard device. An automatic diagnosis of atrial fibrillation made with the tested device, and diagnosis of atrial fibrillation is made by the investigators with gold standard device. Diagnosis results include: &quot;with atrial fibrillation (AF)&quot;, &quot;without atrial fibrillation (No AF)&quot;, or &quot;indecipherable&quot;.&#xD;
After the diagnosis, the number of &quot;with atrial fibrillation (AF)&quot;, &quot;without atrial fibrillation (No AF)&quot;, or &quot;indecipherable&quot; cases measured by the two devices are calculated according to table 1, and then the results are evaluated for 3×3 matching consistency.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation</measure>
    <time_frame>second 60</time_frame>
    <description>Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Per the protocol, only readable and classifiable (classifiable analysis set) paired recordings are included in the diagnostic performance assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waveform qualitative assessment 1</measure>
    <time_frame>second 60</time_frame>
    <description>1)The proportion of paired ECG strips appear to overlay to the unaided eye &gt; 0.80.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waveform qualitative assessment 2</measure>
    <time_frame>second 60</time_frame>
    <description>2)The proportion of paired R-wave amplitude measurements within 2 mm of each other &gt; 0.80</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety measures 1</measure>
    <time_frame>second 60</time_frame>
    <description>1.Scoring system for skin reaction:No erythema, score 0; Very slight erythema (barely perceptible), score 1; Well-defined erythema, score2;Moderate erythema, score 3;Severe erythema (beet-redness) to eschar formation preventing grading of erythema, score 4.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety measures 2</measure>
    <time_frame>second 60</time_frame>
    <description>2. Adverse event (AE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety measures 3</measure>
    <time_frame>second 60</time_frame>
    <description>3. Equipment defector failure for example: unable to wear, no results output, signal interruption.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>use two kinds of device successively</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wearable Dynamic ECG Recorder</intervention_name>
    <description>use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation</description>
    <arm_group_label>use two kinds of device successively</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>12-lead ECG recordings</intervention_name>
    <description>use a 12-lead ECG recordings to record heart rate and atrial fibrillation</description>
    <arm_group_label>use two kinds of device successively</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - All study participants must be able to provide written informed consent prior to&#xD;
             study procedure. This study has 2 Phases.&#xD;
&#xD;
        Phase 1:&#xD;
&#xD;
          -  Health conscious individuals&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
        Phase 2:&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
          -  non critical patients ever diagnosed with atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • &lt; 18 years old&#xD;
&#xD;
               -  Unable to consent&#xD;
&#xD;
        Phase 1:&#xD;
&#xD;
          -  &gt; 80 years of age&#xD;
&#xD;
          -  Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction,&#xD;
             congestive heart failure)&#xD;
&#xD;
          -  current status of non-sinus heart rhythm&#xD;
&#xD;
        Phase 2:&#xD;
&#xD;
        - Critical patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ruogu li, MD</last_name>
    <phone>86-013916139778</phone>
    <email>Pengyimin1977@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Chest hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruogu Li, MD</last_name>
      <phone>86-013916139778</phone>
      <email>Pengyimin1977@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 5, 2020</last_update_submitted>
  <last_update_submitted_qc>July 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Ruogu.li</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </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>


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/NCT04462653
org study id: BZYL-5-1
nct id: NCT04462653
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation
      diagnosis between the Wearable Dynamic ECG Recorder and the Control device.

      In this investigation, the following indicators is also evaluated:

        1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
           compared with physician-adjudicated Gold Standard ECG recorder.

        2. Waveform qualitative assessment

        3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54
           subjects with atrial fibrillation diagnosis in phase II) are enrolled in the
           investigation according to the criteria.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Consistent rate of atrial fibrillation diagnosis
time frame: second 60
description: Electrical signals from ECG electrodes are collected with tested device and gold standard device. An automatic diagnosis of atrial fibrillation made with the tested device, and diagnosis of atrial fibrillation is made by the investigators with gold standard device. Diagnosis results include: "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable".
After the diagnosis, the number of "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable" cases measured by the two devices are calculated according to table 1, and then the results are evaluated for 3×3 matching consistency.
measure: Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation
time frame: second 60
description: Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Per the protocol, only readable and classifiable (classifiable analysis set) paired recordings are included in the diagnostic performance assessment.
measure: waveform qualitative assessment 1
time frame: second 60
description: 1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80.
measure: waveform qualitative assessment 2
time frame: second 60
description: 2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80
measure: Safety measures 1
time frame: second 60
description: 1.Scoring system for skin reaction:No erythema, score 0; Very slight erythema (barely perceptible), score 1; Well-defined erythema, score2;Moderate erythema, score 3;Severe erythema (beet-redness) to eschar formation preventing grading of erythema, score 4.
measure: Safety measures 2
time frame: second 60
description: 2. Adverse event (AE)
measure: Safety measures 3
time frame: second 60
description: 3. Equipment defector failure for example: unable to wear, no results output, signal interruption.
arm group label: use two kinds of device successively
arm group type: Experimental
description: the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation
intervention type: Device
intervention name: Wearable Dynamic ECG Recorder
description: use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
arm group label: use two kinds of device successively
intervention type: Device
intervention name: 12-lead ECG recordings
description: use a 12-lead ECG recordings to record heart rate and atrial fibrillation
arm group label: use two kinds of device successively
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ruogu li, MD
phone: 86-013916139778
email: Pengyimin1977@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Ruogu.li
investigator title: Chief Physician
mesh term: Atrial Fibrillation