<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/NCT03015363</url>
  </required_header>
  <id_info>
    <org_study_id>RS#: 2013-1919</org_study_id>
    <nct_id>NCT03015363</nct_id>
  </id_info>
  <brief_title>Clinical Calibration &amp; Validation of a Next-Generation Blood Pressure Monitor for Patient Management</brief_title>
  <acronym>CCV</acronym>
  <official_title>Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular Research New Brunswick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Horizon Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cloud DX Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Brunswick Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiovascular Research New Brunswick</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate&#xD;
      and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard&#xD;
      for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient&#xD;
      participants who are scheduled for an elective cardiac catheterization procedure for&#xD;
      clinically valid reasons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that&#xD;
      is licensed by Health Canada with Food and Drug Administration approval. Systolic and&#xD;
      diastolic pressures are measured via the arterial pulse waveform of the left radial artery.&#xD;
      Initially, the blood pressure algorithm was created and calibrated using the auscultatory&#xD;
      method. The purpose of this study is to calibrate the device to the clinical gold standard of&#xD;
      peripheral and central intra-arterial pressures.&#xD;
&#xD;
      The device acquires a pulse signal in real-time, stores signal and measurement data, and&#xD;
      displays stored signal and measurement data for interpretation via internet servers where it&#xD;
      is accessible by end-users (physicians and/or patients). The system provides secure accounts&#xD;
      for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers&#xD;
      are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance:&#xD;
      1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via&#xD;
      website, 4) self-encrypting hard-drives rendered useless if removed from the server.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Systolic Pressure</measure>
    <time_frame>Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.</time_frame>
    <description>Central aortic pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Pressure</measure>
    <time_frame>Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.</time_frame>
    <description>Central aortic pressure (mm Hg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Pressure</measure>
    <time_frame>Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.</time_frame>
    <description>Peripheral arterial pressure (mm Hg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Pressure</measure>
    <time_frame>Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.</time_frame>
    <description>Peripheral arterial pressure (mm Hg)</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Hypertension</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for an elective, non-emergent cardiac catheterization with right radial&#xD;
        access; exclusion criteria being no history of peripheral vascular disease, no previous&#xD;
        coronary artery bypass graft, no precious percutaneous coronary intervention, abdominal&#xD;
        aortic aneurysm, arrhythmia, hand/body tremor, nor bilateral arm pressure inequality during&#xD;
        history and physical.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 19 years of age&#xD;
&#xD;
          -  Patients recommended by their cardiologist for a first-time, elective cardiac&#xD;
             catheterization procedure&#xD;
&#xD;
          -  Wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.)&#xD;
&#xD;
          -  Bilateral arm blood pressure equality (systolic within ±10mmHg; diastolic within&#xD;
             ±5mmHg) on 2 separate readings (Nurse Associate &amp; TRA)&#xD;
&#xD;
          -  Willing to volunteer to participate and to sign the study specific informed consent&#xD;
             form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No history of peripheral vascular disease, no previous percutaneous coronary&#xD;
             intervention, nor previous coronary artery bypass graft&#xD;
&#xD;
          -  No arrhythmia&#xD;
&#xD;
          -  No abdominal aortic aneurysm&#xD;
&#xD;
          -  No hand/body tremor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sohrab Lutchmedial, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular Research New Brunswick</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Horizon Health Network</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.clouddx.com/</url>
    <description>Device company website</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>August 3, 2021</results_first_submitted>
  <results_first_submitted_qc>August 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2021</results_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiovascular Research New Brunswick</investigator_affiliation>
    <investigator_full_name>Sohrab Lutchmedial, MD, FRCPC</investigator_full_name>
    <investigator_title>Co-Director of CVR-NB/ Director of NBHC Catheterization Laboratory</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Telemonitoring</keyword>
  <keyword>Vital signs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 37 eligible patients voluntarily consented to participate in the study, although 3 participants withdrew and 14 participants failed to meet the study eligibility criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Prospective Cohort (1)</title>
          <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prospective Cohort (1)</title>
          <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.0" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dyslipidemia (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Systolic Pressure</title>
        <description>Central aortic pressure (mmHg)</description>
        <time_frame>Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.</time_frame>
        <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort (1)</title>
            <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Pressure</title>
          <description>Central aortic pressure (mmHg)</description>
          <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.4" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Pressure</title>
        <description>Central aortic pressure (mm Hg)</description>
        <time_frame>Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.</time_frame>
        <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort (1)</title>
            <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Pressure</title>
          <description>Central aortic pressure (mm Hg)</description>
          <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.4" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Pressure</title>
        <description>Peripheral arterial pressure (mm Hg)</description>
        <time_frame>Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.</time_frame>
        <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort (1)</title>
            <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Pressure</title>
          <description>Peripheral arterial pressure (mm Hg)</description>
          <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.7" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Pressure</title>
        <description>Peripheral arterial pressure (mm Hg)</description>
        <time_frame>Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.</time_frame>
        <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort (1)</title>
            <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Pressure</title>
          <description>Peripheral arterial pressure (mm Hg)</description>
          <population>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Prospective Cohort (1)</title>
          <description>Voluntarily consented patient participants scheduled for an elective, non-emergent cardiac catheterization with right radial access.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was an iterative process in the calibration and validation of the Cloud DX, Inc. Pulsewave Health Monitor oscillometric (automatic) wrist cuff device. The device has not yet been calibrated and validated via the ISO 81060-2_2020 'universal' protocol, although this requirement is currently in progress.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sohrab Lutchmedial, MD, FRCP(C)</name_or_title>
      <organization>CardioVascular Research New Brunswick (CVR-NB)</organization>
      <phone>506-648-6101</phone>
      <email>sohrab.lutchmedial@horizonnb.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03015363
org study id: RS#: 2013-1919
nct id: NCT03015363
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate
      and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard
      for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient
      participants who are scheduled for an elective cardiac catheterization procedure for
      clinically valid reasons.
The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that
      is licensed by Health Canada with Food and Drug Administration approval. Systolic and
      diastolic pressures are measured via the arterial pulse waveform of the left radial artery.
      Initially, the blood pressure algorithm was created and calibrated using the auscultatory
      method. The purpose of this study is to calibrate the device to the clinical gold standard of
      peripheral and central intra-arterial pressures.

      The device acquires a pulse signal in real-time, stores signal and measurement data, and
      displays stored signal and measurement data for interpretation via internet servers where it
      is accessible by end-users (physicians and/or patients). The system provides secure accounts
      for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers
      are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance:
      1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via
      website, 4) self-encrypting hard-drives rendered useless if removed from the server.
observational model: Case-Only
time perspective: Prospective
measure: Systolic Pressure
time frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
description: Central aortic pressure (mmHg)
measure: Diastolic Pressure
time frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure.
description: Central aortic pressure (mm Hg)
measure: Systolic Pressure
time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
description: Peripheral arterial pressure (mm Hg)
measure: Diastolic Pressure
time frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure.
description: Peripheral arterial pressure (mm Hg)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sohrab Lutchmedial, MD, FRCPC
role: Principal Investigator
affiliation: Cardiovascular Research New Brunswick
facility: 
country: Canada
url: http://www.clouddx.com/
description: Device company website
responsible party type: Principal Investigator
investigator affiliation: Cardiovascular Research New Brunswick
investigator full name: Sohrab Lutchmedial, MD, FRCPC
investigator title: Co-Director of CVR-NB/ Director of NBHC Catheterization Laboratory
mesh term: Hypertension
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was an iterative process in the calibration and validation of the Cloud DX, Inc. Pulsewave Health Monitor oscillometric (automatic) wrist cuff device. The device has not yet been calibrated and validated via the ISO 81060-2_2020 'universal' protocol, although this requirement is currently in progress.
point of contact: 