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/NCT05977335</url>
    </required_header>
    <id_info>
      <org_study_id>AFTs Task Force® CORE/CARD</org_study_id>
      <nct_id>NCT05977335</nct_id>
    </id_info>
    <brief_title>Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)</brief_title>
    <official_title>Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CNSystems Medizintechnik GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CNSystems Medizintechnik GmbH</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>
        Background: The investigational device, &quot;Task Force® CORE&quot; (TFC, CNSystems Medizintechnik&#xD;
        GmbH, Graz, Austria) together with the &quot;Task Force® CARDIO&quot; (TFCARDIO, CNSystems&#xD;
        Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical&#xD;
        device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO)&#xD;
        and derived parameters based on the well established CNAP® (continuous non-invasive arterial&#xD;
        pressure) technology by CNSystems.&#xD;
  &#xD;
        Aim: The primary aim of this prospective, method comparison, open study is data acquisition&#xD;
        for the performance evaluation of the TFC during autonomic function testing in comparison&#xD;
        with an clinically accepted reference method. Setting: The setting of the clinical&#xD;
        investigation will be the autonomic function testing laboratory at the Department of&#xD;
        Neurology, the University Hospital Center Zagreb.&#xD;
  &#xD;
        Inclusion criteria: Patients who are over 18 years and who provide written informed consent.&#xD;
  &#xD;
        Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out&#xD;
        rate of 5%, a total of 75 patients will be included.&#xD;
  &#xD;
        Statistics: Descriptive statistics, values for the percentage error and correlation estimates&#xD;
        will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of&#xD;
        parameter changes and further comparative statistics will be performed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Agreement of blood pressure between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for the 5 minutes supine baseline period</time_frame>
      <description>The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of blood pressure between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver</time_frame>
      <description>The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of blood pressure between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 90 seconds Deep Breathing period</time_frame>
      <description>The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of blood pressure between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 10 minutes head-up tilt table test period</time_frame>
      <description>The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of heart rate between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for the 5 minutes supine baseline period</time_frame>
      <description>The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of heart rate between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver</time_frame>
      <description>The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of heart rate between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 90 seconds Deep Breathing period</time_frame>
      <description>The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of heart rate between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 10 minutes head-up tilt table test period</time_frame>
      <description>The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of cardiac output between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for the 5 minutes supine baseline period</time_frame>
      <description>The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of cardiac output between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver</time_frame>
      <description>The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of cardiac output between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 90 seconds Deep Breathing period</time_frame>
      <description>The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Agreement of cardiac output between investigational and reference device.</measure>
      <time_frame>The agreement is calculated for 10 minutes head-up tilt table test period</time_frame>
      <description>The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Autonomic Dysfunction</condition>
    <condition>Orthostatic Intolerance</condition>
    <arm_group>
      <arm_group_label>Orthostatic Intolerance Patients</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Autonomic Function Testing</intervention_name>
      <description>Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.</description>
      <arm_group_label>Orthostatic Intolerance Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who present at the Referral Center for Autonomic Nervous System of the University&#xD;
          Hospital Center Zagreb referred to autonomous nervous system testing will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (patients aged ≥ 18 years)&#xD;
  &#xD;
            -  Patients giving written informed consent to participate in the study.&#xD;
  &#xD;
            -  Patients with intact perfusion of both hands evidenced by a positive Allen's test.&#xD;
  &#xD;
            -  Patients with orthostatic intolerance will be included&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with vascular implants at the sites of non-invasive BP measurement (fingers&#xD;
               or upper arms)&#xD;
  &#xD;
            -  Very low perfusion in the periphery&#xD;
  &#xD;
            -  Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis&#xD;
               obliterans, collagenosis, severely advanced vascular diseases (PAOD))&#xD;
  &#xD;
            -  Patients with significant edema in the fingers&#xD;
  &#xD;
            -  Patients with atrial fibrillation&#xD;
  &#xD;
            -  Patients with valvular disease of grade 2 or above&#xD;
  &#xD;
            -  Patients with ventricular assist devices&#xD;
  &#xD;
            -  Subjects not passing the Allen's test for both hands.&#xD;
  &#xD;
            -  Patients with a large lateral difference in BP (&gt; 15 mmHg for systolic BP and/or &gt;10&#xD;
               mmHg for diastolic BP) or with same arm measurement differences &gt; 10 mmHg in systolic&#xD;
               or diastolic BP during assessment of lateral differences&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Blood Pressure</keyword>
    <keyword>Hemodynamics</keyword>
    <keyword>Non-invasive</keyword>
    <keyword>Continuous</keyword>
    <keyword>Autonomic Function Testing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autonomic Nervous System Diseases</mesh_term>
      <mesh_term>Primary Dysautonomias</mesh_term>
      <mesh_term>Orthostatic Intolerance</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/NCT05977335
  org study id: AFTs Task Force® CORE/CARD
  nct id: NCT05977335
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik
        GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems
        Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical
        device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO)
        and derived parameters based on the well established CNAP® (continuous non-invasive arterial
        pressure) technology by CNSystems.
  
        Aim: The primary aim of this prospective, method comparison, open study is data acquisition
        for the performance evaluation of the TFC during autonomic function testing in comparison
        with an clinically accepted reference method. Setting: The setting of the clinical
        investigation will be the autonomic function testing laboratory at the Department of
        Neurology, the University Hospital Center Zagreb.
  
        Inclusion criteria: Patients who are over 18 years and who provide written informed consent.
  
        Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out
        rate of 5%, a total of 75 patients will be included.
  
        Statistics: Descriptive statistics, values for the percentage error and correlation estimates
        will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of
        parameter changes and further comparative statistics will be performed.
  observational model: Cohort
  time perspective: Prospective
  measure: Agreement of blood pressure between investigational and reference device.
  time frame: The agreement is calculated for the 5 minutes supine baseline period
  description: The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of blood pressure between investigational and reference device.
  time frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
  description: The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of blood pressure between investigational and reference device.
  time frame: The agreement is calculated for 90 seconds Deep Breathing period
  description: The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of blood pressure between investigational and reference device.
  time frame: The agreement is calculated for 10 minutes head-up tilt table test period
  description: The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of heart rate between investigational and reference device.
  time frame: The agreement is calculated for the 5 minutes supine baseline period
  description: The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of heart rate between investigational and reference device.
  time frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
  description: The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of heart rate between investigational and reference device.
  time frame: The agreement is calculated for 90 seconds Deep Breathing period
  description: The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of heart rate between investigational and reference device.
  time frame: The agreement is calculated for 10 minutes head-up tilt table test period
  description: The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of cardiac output between investigational and reference device.
  time frame: The agreement is calculated for the 5 minutes supine baseline period
  description: The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of cardiac output between investigational and reference device.
  time frame: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
  description: The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of cardiac output between investigational and reference device.
  time frame: The agreement is calculated for 90 seconds Deep Breathing period
  description: The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  measure: Agreement of cardiac output between investigational and reference device.
  time frame: The agreement is calculated for 10 minutes head-up tilt table test period
  description: The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
  arm group label: Orthostatic Intolerance Patients
  intervention type: Diagnostic Test
  intervention name: Autonomic Function Testing
  description: Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.
  arm group label: Orthostatic Intolerance Patients
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Autonomic Nervous System Diseases
  mesh term: Primary Dysautonomias
  mesh term: Orthostatic Intolerance