<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/NCT04477603</url>
  </required_header>
  <id_info>
    <org_study_id>TMF-VV-17471</org_study_id>
    <nct_id>NCT04477603</nct_id>
  </id_info>
  <brief_title>Impella ECP Early Feasibility Study</brief_title>
  <acronym>ECP EFS</acronym>
  <official_title>Use of the Impella ECP in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abiomed Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abiomed Inc.</source>
  <oversight_info>
    <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>
      The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating&#xD;
      the safety of the Impella ECP device in adult patients undergoing an elective high-risk&#xD;
      percutaneous coronary intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, single-arm, feasibility study evaluating the safety of&#xD;
      the Impella ECP device in adult patients undergoing an elective high-risk percutaneous&#xD;
      coronary intervention (HRPCI). Additionally, this study will evaluate the feasibility of&#xD;
      placing the ECP pump across the aortic valve without the use of a guidewire and assess the&#xD;
      ability of the pump to provide sufficient hemodynamic support during a HRPCI. Investigational&#xD;
      device products include: Impella ECP pump system (a percutaneous transvalvular micro-axial&#xD;
      blood pump), 9Fr introducer sheath, and the automated Impella controller with revised console&#xD;
      software to allow control of the Impella ECP.&#xD;
&#xD;
      Following informed consent, subjects eligible for a HRPCI that meet all of the inclusion and&#xD;
      none of the exclusion criteria will be enrolled into the study. The intended coronary&#xD;
      intervention is then carried out under mechanical circulatory support by the Investigational&#xD;
      Device. This device is inserted through a sheath that has been deployed through a femoral&#xD;
      puncture, following crimping of the Impella ECP. After proper placement and wireless passage&#xD;
      of the aortic valve, the device pumps blood from the left ventricle into the aorta. Once the&#xD;
      interventional procedure is completed, the device is weaned and removed. Subjects will be&#xD;
      followed up until 30 days post intervention.&#xD;
&#xD;
      The primary and secondary end points will be summarized and presented without formal&#xD;
      statistical testing. Safety will be assessed by the rate of composite Major Device-Related&#xD;
      Adverse Events, evaluated at the end of the HRPCI procedure. Feasibility is defined as the&#xD;
      successful delivery, initiation and maintenance of sufficient hemodynamic support to increase&#xD;
      in or maintenance the MAP at physiologic levels (&gt; 60 mmHg), evaluated up to the end of&#xD;
      procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: successful hemodynamic support</measure>
    <time_frame>through end of procedure, 1 day</time_frame>
    <description>The feasibility assessment is defined as the successful delivery, initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels (&gt; 60 mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Major Device-Related Adverse Events</measure>
    <time_frame>through end of procedure, 1 day</time_frame>
    <description>The rate of composite Major Device-Related Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>through end of procedure, 1 day</time_frame>
    <description>The ability to complete the entire Impella ECP delivery procedure and pump initiation without device malfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural Success</measure>
    <time_frame>through end of procedure, 1 day</time_frame>
    <description>Technical success with a sufficient flow generation by the pump in order to increase or maintain MAP during the interventional procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of each individual Major Device-Related Adverse Event</measure>
    <time_frame>through end of study, 30 days</time_frame>
    <description>The rate of each individual Major Device-Related Adverse Event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of composite Major Device-Related Adverse Events</measure>
    <time_frame>through end of study, 30 days</time_frame>
    <description>The rate of composite Major Device-Related Adverse Events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>High-risk Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Subjects receiving the Impella ECP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Impella ECP</intervention_name>
    <description>Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.</description>
    <arm_group_label>Subjects receiving the Impella ECP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years and ≤ 90 years&#xD;
&#xD;
          2. Subject has signed the informed consent&#xD;
&#xD;
          3. Scheduled for an elective or urgent high risk percutaneous coronary intervention with&#xD;
             hemodynamic support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing,&#xD;
             including greater than mild aortic stenosis&#xD;
&#xD;
          2. Previous aortic valve replacement or reconstruction&#xD;
&#xD;
          3. Thrombus in left ventricle&#xD;
&#xD;
          4. Subjects with known aortic vessel disease or with aortic dissection&#xD;
&#xD;
          5. Any contraindication that precludes placing an Impella including aortic, iliac or&#xD;
             femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis&#xD;
&#xD;
          6. Prior stroke with any permanent neurologic deficit or any prior intracranial&#xD;
             hemorrhage or any prior subdural hematoma or known intracranial pathology&#xD;
             pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass&#xD;
&#xD;
          7. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.&#xD;
             Cardiogenic shock is defined as: systemic hypotension (systolic BP &lt;90 mmHg or the&#xD;
             need for inotropes/pressors to maintain a systolic BP &gt;90 mmHg) plus one of the&#xD;
             following: any requirement for pressors/inotropes prior to arrival at the&#xD;
             catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of&#xD;
             IABP or any other circulatory support device&#xD;
&#xD;
          8. Infection of the proposed procedural access site or suspected systemic active&#xD;
             infection, including any fever&#xD;
&#xD;
          9. Subject has previously been symptomatic with or hospitalized for COVID-19 unless&#xD;
             he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and has&#xD;
             returned to his/her prior baseline (pre-COVID) clinical condition&#xD;
&#xD;
         10. Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast&#xD;
             media or Study-required medication(s) (i.e., aspirin)&#xD;
&#xD;
         11. Platelet count &lt;75k, bleeding diathesis, coagulopathy or unwilling to receive blood&#xD;
             transfusions&#xD;
&#xD;
         12. Subject is on dialysis&#xD;
&#xD;
         13. Suspected or known pregnancy&#xD;
&#xD;
         14. 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;
         15. 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 endpoint&#xD;
&#xD;
         16. 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>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuck Simonton, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abiomed Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Duane Pinto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seth Bilazarian, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abiomed Inc.</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>
    <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>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HRPCI</keyword>
  <keyword>High-risk percutaneous coronary intervention</keyword>
  <keyword>circulatory support</keyword>
  <keyword>left ventricular unloading</keyword>
  <keyword>Abiomed</keyword>
  <keyword>Impella</keyword>
  <keyword>Impella ECP</keyword>
  <!-- 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/NCT04477603
org study id: TMF-VV-17471
nct id: NCT04477603
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating
      the safety of the Impella ECP device in adult patients undergoing an elective high-risk
      percutaneous coronary intervention.
This is a prospective, multicenter, single-arm, feasibility study evaluating the safety of
      the Impella ECP device in adult patients undergoing an elective high-risk percutaneous
      coronary intervention (HRPCI). Additionally, this study will evaluate the feasibility of
      placing the ECP pump across the aortic valve without the use of a guidewire and assess the
      ability of the pump to provide sufficient hemodynamic support during a HRPCI. Investigational
      device products include: Impella ECP pump system (a percutaneous transvalvular micro-axial
      blood pump), 9Fr introducer sheath, and the automated Impella controller with revised console
      software to allow control of the Impella ECP.

      Following informed consent, subjects eligible for a HRPCI that meet all of the inclusion and
      none of the exclusion criteria will be enrolled into the study. The intended coronary
      intervention is then carried out under mechanical circulatory support by the Investigational
      Device. This device is inserted through a sheath that has been deployed through a femoral
      puncture, following crimping of the Impella ECP. After proper placement and wireless passage
      of the aortic valve, the device pumps blood from the left ventricle into the aorta. Once the
      interventional procedure is completed, the device is weaned and removed. Subjects will be
      followed up until 30 days post intervention.

      The primary and secondary end points will be summarized and presented without formal
      statistical testing. Safety will be assessed by the rate of composite Major Device-Related
      Adverse Events, evaluated at the end of the HRPCI procedure. Feasibility is defined as the
      successful delivery, initiation and maintenance of sufficient hemodynamic support to increase
      in or maintenance the MAP at physiologic levels (> 60 mmHg), evaluated up to the end of
      procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Feasibility: successful hemodynamic support
time frame: through end of procedure, 1 day
description: The feasibility assessment is defined as the successful delivery, initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels (> 60 mmHg)
measure: Safety: Major Device-Related Adverse Events
time frame: through end of procedure, 1 day
description: The rate of composite Major Device-Related Adverse Events
measure: Technical Success
time frame: through end of procedure, 1 day
description: The ability to complete the entire Impella ECP delivery procedure and pump initiation without device malfunction.
measure: Procedural Success
time frame: through end of procedure, 1 day
description: Technical success with a sufficient flow generation by the pump in order to increase or maintain MAP during the interventional procedure.
measure: Rate of each individual Major Device-Related Adverse Event
time frame: through end of study, 30 days
description: The rate of each individual Major Device-Related Adverse Event.
measure: Rate of composite Major Device-Related Adverse Events
time frame: through end of study, 30 days
description: The rate of composite Major Device-Related Adverse Events.
arm group label: Subjects receiving the Impella ECP
arm group type: Experimental
intervention type: Device
intervention name: Impella ECP
description: Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.
arm group label: Subjects receiving the Impella ECP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Chuck Simonton, MD
role: Study Director
affiliation: Abiomed Inc.
last name: Duane Pinto, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
last name: Seth Bilazarian, MD
role: Study Director
affiliation: Abiomed Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor