<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/NCT03807622</url>
  </required_header>
  <id_info>
    <org_study_id>2018-05</org_study_id>
    <nct_id>NCT03807622</nct_id>
  </id_info>
  <brief_title>ClearSight System CHN Study</brief_title>
  <official_title>A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</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>
      The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined&#xD;
      with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is&#xD;
      comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The&#xD;
      results of this study may be used for registration and regulatory submissions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 25, 2018</start_date>
  <completion_date type="Actual">October 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 17, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Output using the Non-invasive ClearSight System</measure>
    <time_frame>Expected to last no more than 6 hours</time_frame>
    <description>Cardiac Output using the Non-invasive ClearSight System</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage error (PE) between the ClearSight System CO and TD</measure>
    <time_frame>Expected to last no more than 6 hours</time_frame>
    <description>The percentage error (PE) between the ClearSight System CO and TD</description>
  </secondary_outcome>
  <enrollment type="Actual">125</enrollment>
  <condition>Patient With Clinically Indicated Invasive Monitoring</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System</intervention_name>
    <description>EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective major cardiothoracic surgery with an indwelling PA catheter.&#xD;
        The surgical intervention includes, but is not limited to, mitral valve surgery or coronary&#xD;
        artery bypass grafting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be at least 18 years of age&#xD;
&#xD;
          -  Subjects provide written informed consent prior to trial procedures&#xD;
&#xD;
          -  Subjects' height and weight must be accurately obtained prior to study start.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aortic or tricuspid valve regurgitation&#xD;
&#xD;
          -  Aortic stenosis or aneurysms&#xD;
&#xD;
          -  Cardiac rhythm disorder&#xD;
&#xD;
          -  Patients with extreme contraction of the smooth muscle in the arteries and arterioles&#xD;
             in the lower arm and hand, such as may be present in patients with Raynaud's or&#xD;
             Buerger's disease or with extremely cold hands&#xD;
&#xD;
          -  Inability to place the finger cuff appropriately due to subject anatomy or condition&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Patients being treated with an intra-aortic balloon pump&#xD;
&#xD;
          -  Patient is currently participating in an investigational drug or another device study&#xD;
             that clinically interferes with the study endpoints&#xD;
&#xD;
          -  Intracardiac shunt&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing</name>
      <address>
        <city>Xicheng</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Asia Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei Sheng</state>
        <zip>430072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hospital</name>
      <address>
        <city>Heping</city>
        <state>Tianjin</state>
        <zip>300300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elective Major Cardiothoracic</keyword>
  <keyword>Mitral Valve Surgery</keyword>
  <keyword>Coronary Artery Bypass Grafting</keyword>
  <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/NCT03807622
org study id: 2018-05
nct id: NCT03807622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined
      with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is
      comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The
      results of this study may be used for registration and regulatory submissions.
observational model: Case-Only
time perspective: Prospective
measure: Cardiac Output using the Non-invasive ClearSight System
time frame: Expected to last no more than 6 hours
description: Cardiac Output using the Non-invasive ClearSight System
measure: The percentage error (PE) between the ClearSight System CO and TD
time frame: Expected to last no more than 6 hours
description: The percentage error (PE) between the ClearSight System CO and TD
intervention type: Device
intervention name: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
description: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No