<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/NCT03001674</url>
  </required_header>
  <id_info>
    <org_study_id>IABP_Hemodynamics</org_study_id>
    <nct_id>NCT03001674</nct_id>
  </id_info>
  <brief_title>Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure</brief_title>
  <official_title>Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to develop normative hemodynamic data (means and&#xD;
      standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and&#xD;
      3D-echocardiographic analyses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.</measure>
    <time_frame>24 hours</time_frame>
    <description>We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>IABP recipient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control subjects undergoing left heart catheterization with an LV ejection fraction &gt; 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conductance catheterization</intervention_name>
    <description>CD Leycom Conductance Catheter</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>IABP recipient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or females between 18-75 years of age&#xD;
&#xD;
          -  NYHA Class III-IV heart failure at the time of MEGA deployment&#xD;
&#xD;
          -  Stage C-D systolic heart failure&#xD;
&#xD;
          -  Non-ischemic cardiomyopathy&#xD;
&#xD;
          -  Preserved right ventricular function defined by 2D-echocardiography&#xD;
&#xD;
          -  Clinically indicated left and right heart catheterization and MEGA-IABP placement&#xD;
&#xD;
          -  Clinically indicated MEGA-IABP support for 12 hours minimum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ischemic cardiomyopathy&#xD;
&#xD;
          -  Active myocardial ischemia or acute coronary syndrome&#xD;
&#xD;
          -  Severe peripheral vascular disease&#xD;
&#xD;
          -  Severe aortic or mitral valve insufficiency&#xD;
&#xD;
          -  Severe aortic or mitral valve stenosis&#xD;
&#xD;
          -  Right ventricular failure&#xD;
&#xD;
          -  Inability to tolerate left and right heart catheterization&#xD;
&#xD;
          -  Severe hemodynamic instability defined as a systolic BP &lt;80mmHg despite&#xD;
             vasopressor/inotropic support&#xD;
&#xD;
          -  Sustained ventricular tachycardia (&gt;10 beats) within 24 hours and/or ventricular&#xD;
             fibrillation within 24 hours&#xD;
&#xD;
          -  Pacemaker dependent rhythm&#xD;
&#xD;
          -  Left ventricular thrombus&#xD;
&#xD;
          -  Rapid atrial fibrillation (HR&gt;120 bpm)&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Navin Kapur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>March 27, 2014</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>April 25, 2017</results_first_submitted>
  <results_first_submitted_qc>April 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2017</results_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</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>Heart Failure</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>10 patients with advanced HF from 2014 to 2015 at Tufts Medical Center referred for clinically indicated RHC and IABP placement prior to LVAD surgery. Five control subjects undergoing left heart catheterization with an LV ejection fraction &gt; 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>IABP Recipient</title>
          <description>Prospective, double-arm, pilot study.&#xD;
Conductance catheterization: CD Leycom Conductance Catheter</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Control subjects undergoing left heart catheterization with an LV ejection fraction &gt; 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IABP Recipient</title>
          <description>Conductance catheterization: CD Leycom Conductance Catheter</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Conductance catheterization: CD Leycom Conductance Catheter</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" spread="14"/>
                    <measurement group_id="B2" value="54" spread="13"/>
                    <measurement group_id="B3" value="56" spread="13"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Surface Area (BSA)</title>
          <units>m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.07" spread="0.33"/>
                    <measurement group_id="B2" value="2.22" spread="0.15"/>
                    <measurement group_id="B3" value="2.12" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.</title>
        <description>We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IABP Recipient</title>
            <description>Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.&#xD;
Conductance catheterization: CD Leycom Conductance Catheter</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control subjects undergoing left heart catheterization with an LV ejection fraction &gt; 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.&#xD;
Conductance catheterization: CD Leycom Conductance Catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.</title>
          <description>We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.</description>
          <units>mmHg-mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stroke work without IABP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="939" spread="302"/>
                    <measurement group_id="O2" value="5628" spread="2866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke work with IABP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="667" spread="210"/>
                    <measurement group_id="O2" value="NA" spread="NA">Number value for control patients (who did not receive an IABP) should be 'not applicable'</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>IABP Recipient</title>
          <description>Prospective, double-arm, pilot study.&#xD;
Conductance catheterization: CD Leycom Conductance Catheter</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Control subjects undergoing left heart catheterization with an LV ejection fraction &gt; 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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>Small number of patients studied. Non-randomized study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Navin Kapur</name_or_title>
      <organization>Tufts Medical Center</organization>
      <phone>617 636 0720</phone>
      <email>nkapur@tuftsmedicalcenter.org</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/NCT03001674
org study id: IABP_Hemodynamics
nct id: NCT03001674
lead sponsor: 
has dmc: No
The primary objective of this study is to develop normative hemodynamic data (means and
      standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and
      3D-echocardiographic analyses.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
time frame: 24 hours
description: We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.
arm group label: IABP recipient
arm group type: Experimental
description: Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.
arm group label: Control
arm group type: Experimental
description: Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
intervention type: Device
intervention name: Conductance catheterization
description: CD Leycom Conductance Catheter
arm group label: Control
arm group label: IABP recipient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Navin Kapur, MD
role: Principal Investigator
affiliation: Tufts Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small number of patients studied. Non-randomized study.
point of contact: 