xml: <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/NCT06007963</url>
    </required_header>
    <id_info>
      <org_study_id>62048</org_study_id>
      <nct_id>NCT06007963</nct_id>
    </id_info>
    <brief_title>Impella in Cardiogenic Shock Registry</brief_title>
    <acronym>Impella</acronym>
    <official_title>Impella Left or Right Ventricular Support in Cardiogenic Shock</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitaire Ziekenhuizen KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitaire Ziekenhuizen KU Leuven</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to evaluate the safety, efficacy and clinical usefulness of a&#xD;
        mechanical support strategy with the impella device.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the last two decades mortality from acute coronary syndromes has decreased dramatically&#xD;
        thanks to aggressive use of coronary revascularization techniques. In cardiogenic shock&#xD;
        however, a dramatique decrease in mortality since the introduction of primary PCI has not&#xD;
        been seen, probably because restoring only coronary flow does not necessary imply restoration&#xD;
        of whole body organ perfusion as long as the heart has not recuperated. To restore perfusion&#xD;
        there are currently two options: catecholamine drugs (that can increase native cardiac output&#xD;
        but at the price of increased oxygen consumption by the myocardium) or mechanical cardiac&#xD;
        support (which provides artificial blood flow to the body, but depending on the device&#xD;
        increases or decreases myocardial oxygen consumption). The dose of catecholamines used in&#xD;
        cardiogenic shock patients is linearly correlated with worse outcome, suggesting a negative&#xD;
        effect. Several mechanical cardiac support devices have been developed, but only some can be&#xD;
        placed percutaneously and are available in Belgium.&#xD;
  &#xD;
        The intra-aortic balloon pump, which was the first and remains the least invasive device,&#xD;
        failed to show any mortality benefit in cardiogenic shock. A possible explanation could be&#xD;
        the fact that this device device aims at restoring coronary rather than organ perfusion,&#xD;
        since the increase in cardiac output after starting the balloon pump is very limited.&#xD;
        Extracorporeal membrane oxygenation (ECMO) is an alternative to support organ perfusion, that&#xD;
        provides the highest blood flow, but tends to increase cardiac work because it increases&#xD;
        afterload. ECMO is also the most invasive percutaneous device since this requires two large&#xD;
        bore access catheters to the patients' circulation and the blood flows through a bigger&#xD;
        circuit, making it more prone to coagulation defects. The left side Impella device is a&#xD;
        micro-axial continuous flow pump which sucks blood from the left ventricle towards the&#xD;
        ascending aorta with the goal of increasing blood flow to the body while at the same time&#xD;
        unloading the heart. This device only requires one access site (mostly smaller caliber as&#xD;
        well). There is extensive experience with the left sided Impella device; its safety and&#xD;
        efficacy have already been demonstrated in the past. The first results of the recent 'Detroit&#xD;
        Cardiogenic Shock Initiative', aiming at early institution of mechanical support with the&#xD;
        Impella device, already showed a significant decrease in mortality in participating centers.&#xD;
        The Impella RP device is one of the only percutaneous devices that provide high flow support&#xD;
        to the right ventricle by pushing blood from the inferior vena cava to the pulmonary artery.&#xD;
        In the FDA approval study safety was demonstrated and outcomes where significantly better&#xD;
        with the devices compared to historical controls.&#xD;
  &#xD;
        An evolution to an earlier and as minimally invasive as possible strategy for mechanical&#xD;
        support in cardiogenic shock is seen as well in the UZ Leuven cardiac intensive care unit.&#xD;
        With an expierience of more than 20 years with the impella device in UZ Leuven (among the&#xD;
        first to use the earlier versions of the device) this device was chosen as the first step to&#xD;
        support the heart (in case of failure of one ventricle without need for additional&#xD;
        oxygenation), with ECMO in second line since it is more invasive but delivers biventricular&#xD;
        support with capability of higher flows. There are no high quality randomized controlled&#xD;
        trials that compare one mechanical support strategy to another (except for one study in which&#xD;
        almost 90% of patients were included after cardiac arrest, mostly dying from withdrawal of&#xD;
        therapy). To improve quality, it seems key to measure outcomes and analyze these results as&#xD;
        thoroughly as possible. For this reason, a prospective registry for all cardiogenic shock&#xD;
        patients in the cardiac ICU, treated with the Impella device, is started.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 29, 2021</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Mortality</measure>
      <time_frame>30 day and 1 year</time_frame>
      <description>Description: mortality: as assessed via patient file, contact with patient, general physician or family memeber</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Myocardial recovery</measure>
      <time_frame>30 dat and 1 year</time_frame>
      <description>myocardial recovery: assesses as the difference between echocardiographic left ventricular ejection fracton assessment (baseline versus follow-up time point)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Shock, Cardiogenic</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Treatment with impella device.</intervention_name>
      <description>Impella percutaneous mechanical supported patients will be included after revision to support.</description>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Coagulation tests&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          A/ Awake patients will only be asked for consent after getting oral and written&#xD;
          information.&#xD;
  &#xD;
          B/ Ventilated patients will be included after consent is obtained from legal&#xD;
          representative. After improvent of patients status consent will be obtained from the&#xD;
          patient.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Patients admitted for cardiogenic shock (defined as SBP &lt;90 mmHg without&#xD;
               vasopressors/inotropics or elevated serum lactate).&#xD;
  &#xD;
          AND&#xD;
  &#xD;
          • Treatment with Impella device&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tom Adriaenssens, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tom Adriaenssens, MD PhD</last_name>
      <phone>016/341392</phone>
      <email>tom.adriaenssens@uzleuven.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Walter Desmet, Prof. dr.</last_name>
      <email>walter.desmet@uzleuven.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospitals Leuven, Gasthuisberg</name>
        <address>
          <city>Leuven</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tom Adriaenssens, MD</last_name>
        <phone>32-16-341392</phone>
        <email>tom.adriaenssens@uzleuven.be</email>
      </contact>
      <contact_backup>
        <last_name>Marina Claes</last_name>
        <phone>016342461</phone>
        <email>marina.claes@uzleuven.be</email>
      </contact_backup>
      <investigator>
        <last_name>Tom Adriaenssens, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Walter Desmet, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Peter Sinnaeve, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christophe Dubois, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Johan Bennett</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pierluigi Lesizza</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pascal Frederiks</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>April 3, 2019</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Shock, Cardiogenic</mesh_term>
      <mesh_term>Shock</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007963
  org study id: 62048
  nct id: NCT06007963
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to evaluate the safety, efficacy and clinical usefulness of a
        mechanical support strategy with the impella device.
  In the last two decades mortality from acute coronary syndromes has decreased dramatically
        thanks to aggressive use of coronary revascularization techniques. In cardiogenic shock
        however, a dramatique decrease in mortality since the introduction of primary PCI has not
        been seen, probably because restoring only coronary flow does not necessary imply restoration
        of whole body organ perfusion as long as the heart has not recuperated. To restore perfusion
        there are currently two options: catecholamine drugs (that can increase native cardiac output
        but at the price of increased oxygen consumption by the myocardium) or mechanical cardiac
        support (which provides artificial blood flow to the body, but depending on the device
        increases or decreases myocardial oxygen consumption). The dose of catecholamines used in
        cardiogenic shock patients is linearly correlated with worse outcome, suggesting a negative
        effect. Several mechanical cardiac support devices have been developed, but only some can be
        placed percutaneously and are available in Belgium.
  
        The intra-aortic balloon pump, which was the first and remains the least invasive device,
        failed to show any mortality benefit in cardiogenic shock. A possible explanation could be
        the fact that this device device aims at restoring coronary rather than organ perfusion,
        since the increase in cardiac output after starting the balloon pump is very limited.
        Extracorporeal membrane oxygenation (ECMO) is an alternative to support organ perfusion, that
        provides the highest blood flow, but tends to increase cardiac work because it increases
        afterload. ECMO is also the most invasive percutaneous device since this requires two large
        bore access catheters to the patients' circulation and the blood flows through a bigger
        circuit, making it more prone to coagulation defects. The left side Impella device is a
        micro-axial continuous flow pump which sucks blood from the left ventricle towards the
        ascending aorta with the goal of increasing blood flow to the body while at the same time
        unloading the heart. This device only requires one access site (mostly smaller caliber as
        well). There is extensive experience with the left sided Impella device; its safety and
        efficacy have already been demonstrated in the past. The first results of the recent 'Detroit
        Cardiogenic Shock Initiative', aiming at early institution of mechanical support with the
        Impella device, already showed a significant decrease in mortality in participating centers.
        The Impella RP device is one of the only percutaneous devices that provide high flow support
        to the right ventricle by pushing blood from the inferior vena cava to the pulmonary artery.
        In the FDA approval study safety was demonstrated and outcomes where significantly better
        with the devices compared to historical controls.
  
        An evolution to an earlier and as minimally invasive as possible strategy for mechanical
        support in cardiogenic shock is seen as well in the UZ Leuven cardiac intensive care unit.
        With an expierience of more than 20 years with the impella device in UZ Leuven (among the
        first to use the earlier versions of the device) this device was chosen as the first step to
        support the heart (in case of failure of one ventricle without need for additional
        oxygenation), with ECMO in second line since it is more invasive but delivers biventricular
        support with capability of higher flows. There are no high quality randomized controlled
        trials that compare one mechanical support strategy to another (except for one study in which
        almost 90% of patients were included after cardiac arrest, mostly dying from withdrawal of
        therapy). To improve quality, it seems key to measure outcomes and analyze these results as
        thoroughly as possible. For this reason, a prospective registry for all cardiogenic shock
        patients in the cardiac ICU, treated with the Impella device, is started.
  observational model: Case-Only
  time perspective: Prospective
  measure: Mortality
  time frame: 30 day and 1 year
  description: Description: mortality: as assessed via patient file, contact with patient, general physician or family memeber
  measure: Myocardial recovery
  time frame: 30 dat and 1 year
  description: myocardial recovery: assesses as the difference between echocardiographic left ventricular ejection fracton assessment (baseline versus follow-up time point)
  intervention type: Procedure
  intervention name: Treatment with impella device.
  description: Impella percutaneous mechanical supported patients will be included after revision to support.
  Coagulation tests
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Tom Adriaenssens, MD PhD
  role: Study Chair
  affiliation: Universitaire Ziekenhuizen KU Leuven
  last name: Tom Adriaenssens, MD PhD
  phone: 016/341392
  email: tom.adriaenssens@uzleuven.be
  last name: Walter Desmet, Prof. dr.
  email: walter.desmet@uzleuven.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Shock, Cardiogenic
  mesh term: Shock