<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/NCT04465201</url>
  </required_header>
  <id_info>
    <org_study_id>VV-TMF-16540</org_study_id>
    <nct_id>NCT04465201</nct_id>
  </id_info>
  <brief_title>The Smart Pump Study</brief_title>
  <official_title>Advanced Impella® SmartAssist® System for Patient Monitoring &amp; Treatment: The Smart Pump Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abiomed Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abiomed Inc.</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate that the Impella® Hemodynamic Platform (the &quot;Study Device&quot;) is safe, and&#xD;
      measurements obtained are as good as currently used methods. These measurements include how&#xD;
      much pressure the heart is generating and how much blood your heart is pumping during the&#xD;
      PCI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The ability to calculate and display cardiac output (CO).</measure>
    <time_frame>Through study completion, approximately 2 days</time_frame>
    <description>Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the &quot;number of times CO was successfully completed, and CO is displayed&quot; divided by the &quot;number of times the pinging sequence was attempted&quot;</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Cardiac Output</condition>
  <arm_group>
    <arm_group_label>Subjects receiving the Impella/Impella® Hemodynamics platform</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Impella CP with Smart Assist (Circulatory Support System)</intervention_name>
    <description>Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission.</description>
    <arm_group_label>Subjects receiving the Impella/Impella® Hemodynamics platform</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Subject presents for elective PCI&#xD;
&#xD;
          3. Subject or the subject's LAR has signed the informed consent&#xD;
&#xD;
          4. Subject indicated for Impella® support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any contraindication or inability to place an Impella® including tortuous vascular&#xD;
             anatomy, femoral bruits or absent pedal pulses&#xD;
&#xD;
          2. Cardiogenic shock defined as systemic hypotension (SBP&lt;90mmHg or the need for&#xD;
             inotropes/vasopressors to maintain an SBP &gt;90mmHg) plus one of the following:&#xD;
&#xD;
               1. Any requirement for inotropes/vasopressors prior to arrival at the catherization&#xD;
                  lab&#xD;
&#xD;
               2. Clinical evidence of end organ hypoperfusion&#xD;
&#xD;
               3. Use of IABP or any other circulatory support device&#xD;
&#xD;
          3. Suspected systemic active infection&#xD;
&#xD;
          4. Suspected or known pregnancy&#xD;
&#xD;
          5. Known contraindication to heparin, pork, pork products, or contrast media&#xD;
&#xD;
          6. Subject has other medical, social, or psychological problems that, in the opinion of&#xD;
             the Investigator, compromises the subject's ability to give written informed consent&#xD;
             and/or to comply with study procedures&#xD;
&#xD;
          7. Participation in the active treatment or follow-up phase of another clinical study of&#xD;
             an investigational drug or device which has not reached its primary end point.&#xD;
&#xD;
          8. Subject belongs to a vulnerable population [Vulnerable subject populations are defined&#xD;
             as individuals with mental disability, persons in nursing homes, children,&#xD;
             impoverished persons, homeless persons, nomads, refugees, and those permanently&#xD;
             incapable of giving informed consent. Vulnerable populations also may include members&#xD;
             of a group with a hierarchical structure such as university students, subordinate&#xD;
             hospital and laboratory personnel, employees of the Sponsor, members of the armed&#xD;
             forces, and persons kept in detention&#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>Ochsner Clinical Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension St. John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04465201
org study id: VV-TMF-16540
nct id: NCT04465201
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and
      measurements obtained are as good as currently used methods. These measurements include how
      much pressure the heart is generating and how much blood your heart is pumping during the
      PCI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The ability to calculate and display cardiac output (CO).
time frame: Through study completion, approximately 2 days
description: Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the "number of times CO was successfully completed, and CO is displayed" divided by the "number of times the pinging sequence was attempted"
arm group label: Subjects receiving the Impella/Impella® Hemodynamics platform
arm group type: Experimental
intervention type: Device
intervention name: Impella CP with Smart Assist (Circulatory Support System)
description: Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission.
arm group label: Subjects receiving the Impella/Impella® Hemodynamics platform
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No