<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/NCT04451798</url>
  </required_header>
  <id_info>
    <org_study_id>SMW 07</org_study_id>
    <nct_id>NCT04451798</nct_id>
  </id_info>
  <brief_title>Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic</brief_title>
  <acronym>JenaMACS</acronym>
  <official_title>JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jena University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leipzig</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, monocentric open-label observational study for the assessment of acute&#xD;
      hemodynamic effects following implantation of the IMPELLA CP cardiac support device&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemodynamic Parameters due to PA catheterisation</measure>
    <time_frame>Day 1</time_frame>
    <description>Pulmonary capillary Wedge pressure in dependence of Impella pump level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Echocardiographic Parameters of left and right heart function</measure>
    <time_frame>Day 1</time_frame>
    <description>LV- size in dependence of Impella pump level</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cardiogenic Shock</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Impella implantation and hemodynamic measurement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Impella CP microaxial pump</intervention_name>
    <description>ramp test</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock following acute MI or acute heart failure with&#xD;
&#xD;
               -  systolic BP &lt; 90 mm Hg over &gt; 30 min or inotropes for support of cardiac output&#xD;
                  and BP with&#xD;
&#xD;
               -  signs of left heart failure and pulmonary congestion&#xD;
&#xD;
               -  and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or&#xD;
                  serum lactate &gt;2 mmol/l&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>91 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven Möbius-Winkler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universityhospital Jena</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>SWven Möbius-Winkler, MD</last_name>
    <phone>0049-3641-9324503</phone>
    <email>sven.moebius-winkler@med.uni-jena.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christian P Schulze, MD</last_name>
    <phone>0049-3641-9324103</phone>
    <email>christian.schulze@med.uni-jena.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Jena</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven Möbius-Winkler, MD, PhD</last_name>
      <phone>0049-34619324503</phone>
      <email>svne.moebius-winkler@med.uni-jena.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>March 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leipzig</investigator_affiliation>
    <investigator_full_name>Sven Möbius-Winkler</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Impella</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Cardiogenic</mesh_term>
  </condition_browse>
  <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/NCT04451798
org study id: SMW 07
nct id: NCT04451798
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Prospective, monocentric open-label observational study for the assessment of acute
      hemodynamic effects following implantation of the IMPELLA CP cardiac support device
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Hemodynamic Parameters due to PA catheterisation
time frame: Day 1
description: Pulmonary capillary Wedge pressure in dependence of Impella pump level
measure: Echocardiographic Parameters of left and right heart function
time frame: Day 1
description: LV- size in dependence of Impella pump level
arm group label: Intervention
arm group type: Experimental
description: Impella implantation and hemodynamic measurement
intervention type: Device
intervention name: Impella CP microaxial pump
description: ramp test
arm group label: Intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 91 Years
healthy volunteers: No
last name: Sven Möbius-Winkler, MD
role: Principal Investigator
affiliation: Universityhospital Jena
last name: SWven Möbius-Winkler, MD
phone: 0049-3641-9324503
email: sven.moebius-winkler@med.uni-jena.de
last name: Christian P Schulze, MD
phone: 0049-3641-9324103
email: christian.schulze@med.uni-jena.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Leipzig
investigator full name: Sven Möbius-Winkler
investigator title: Principal Investigator, Clinical Professor
mesh term: Shock, Cardiogenic
sharing ipd: No