<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/NCT04478890</url>
  </required_header>
  <id_info>
    <org_study_id>ANES-2020-28725</org_study_id>
    <nct_id>NCT04478890</nct_id>
  </id_info>
  <brief_title>Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement</brief_title>
  <official_title>Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement at the University of Minnesota Medical Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will include the placement of a pressure volume (PV) loop catheter in the right&#xD;
      atrium of patients undergoing left ventricular assist device (LVAD) placement and measure&#xD;
      relevant PV loop data. Transesophageal echocardiography (TEE) and pulmonary artery (PA)&#xD;
      catheter parameters as comparators to the PV loop will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective observational study design to characterize right ventricular&#xD;
      function in 5 consecutive patients undergoing LVAD implantation at the University of&#xD;
      Minnesota Medical Center (UMMC). Pre-, intra- and postoperative care delivery to all enrolled&#xD;
      and consented patients will meet the standards of care otherwise delivered to patients&#xD;
      undergoing LVAD implantation at UMMC; care delivery will be at the discretion of the clinical&#xD;
      care team and will not be altered based on the output of the right ventricular high-fidelity&#xD;
      conductance catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2021</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 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>Stroke volume</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>Stroke volume will be reported in units of millilitres per square metre</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>Heart rate will be reported in units of beats per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ejection fraction</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>Ejection fraction will be reported as a percent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>Cardiac output will be reported in units of milliliters per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-systolic pressure</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>End-systolic pressure will be reported in units of mmHG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-systolic volume</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>End-systolic volume will be reported in units of milliliters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-diastolic pressure</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>End-diastolic pressure will be reported in units of mmHG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-diastolic volume</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>End-diastolic volume will be reported in units of milliliters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Right ventricular dP/dt</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>Right ventricular dP/dt will be reported in units of mmHg per second</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke work</measure>
    <time_frame>Approximately 4-6 hours</time_frame>
    <description>Stroke work will be reported in units of gram meters (g*m)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Right Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>Observational Group</arm_group_label>
    <description>Characterize right ventricular function while undergoing LVAD implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hemodynamic assessment</intervention_name>
    <description>Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter</description>
    <arm_group_label>Observational Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients 18 years or older undergoing left ventricular assist device (LVAD)&#xD;
        placement at the University of Minnesota Medical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients undergoing left ventricular assist device (LVAD) placement at the University of&#xD;
        Minnesota Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of internal jugular vein thrombosis or known reasons for not&#xD;
             being able to thread a central venous catheter through either internal jugular vein&#xD;
&#xD;
          -  Patients with a history of known esophageal strictures, esophageal or stomach cancer,&#xD;
             esophageal varices, or any patient in whom a TEE is contraindicated&#xD;
&#xD;
          -  Patients with permanent pacemakers whose right ventricle is being paced and not in&#xD;
             normal sinus rhythm&#xD;
&#xD;
          -  Patients unable to consent to participating in the study&#xD;
&#xD;
          -  Patients who are pregnant will be excluded, as part of standard care, all female&#xD;
             patients are screened for pregnancy prior to surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tjorvi Perry, MD, MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tjorvi E Perry, MD, MMSc</last_name>
    <phone>6124027900</phone>
    <email>perry655@umn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 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>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Right</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/NCT04478890
org study id: ANES-2020-28725
nct id: NCT04478890
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will include the placement of a pressure volume (PV) loop catheter in the right
      atrium of patients undergoing left ventricular assist device (LVAD) placement and measure
      relevant PV loop data. Transesophageal echocardiography (TEE) and pulmonary artery (PA)
      catheter parameters as comparators to the PV loop will be recorded.
This will be a prospective observational study design to characterize right ventricular
      function in 5 consecutive patients undergoing LVAD implantation at the University of
      Minnesota Medical Center (UMMC). Pre-, intra- and postoperative care delivery to all enrolled
      and consented patients will meet the standards of care otherwise delivered to patients
      undergoing LVAD implantation at UMMC; care delivery will be at the discretion of the clinical
      care team and will not be altered based on the output of the right ventricular high-fidelity
      conductance catheters.
observational model: Cohort
time perspective: Prospective
measure: Stroke volume
time frame: Approximately 4-6 hours
description: Stroke volume will be reported in units of millilitres per square metre
measure: Heart rate
time frame: Approximately 4-6 hours
description: Heart rate will be reported in units of beats per minute
measure: Ejection fraction
time frame: Approximately 4-6 hours
description: Ejection fraction will be reported as a percent
measure: Cardiac output
time frame: Approximately 4-6 hours
description: Cardiac output will be reported in units of milliliters per minute
measure: End-systolic pressure
time frame: Approximately 4-6 hours
description: End-systolic pressure will be reported in units of mmHG
measure: End-systolic volume
time frame: Approximately 4-6 hours
description: End-systolic volume will be reported in units of milliliters
measure: End-diastolic pressure
time frame: Approximately 4-6 hours
description: End-diastolic pressure will be reported in units of mmHG
measure: End-diastolic volume
time frame: Approximately 4-6 hours
description: End-diastolic volume will be reported in units of milliliters
measure: Right ventricular dP/dt
time frame: Approximately 4-6 hours
description: Right ventricular dP/dt will be reported in units of mmHg per second
measure: Stroke work
time frame: Approximately 4-6 hours
description: Stroke work will be reported in units of gram meters (g*m)
arm group label: Observational Group
description: Characterize right ventricular function while undergoing LVAD implantation
intervention type: Diagnostic Test
intervention name: Hemodynamic assessment
description: Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter
arm group label: Observational Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tjorvi Perry, MD, MMSc
role: Principal Investigator
affiliation: University of Minnesota
last name: Tjorvi E Perry, MD, MMSc
phone: 6124027900
email: perry655@umn.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Right