<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/NCT01674699</url>
  </required_header>
  <id_info>
    <org_study_id>EXCOR PAS</org_study_id>
    <secondary_id>H100004</secondary_id>
    <nct_id>NCT01674699</nct_id>
  </id_info>
  <brief_title>Berlin Heart EXCOR Pediatric Post Approval Study</brief_title>
  <official_title>Berlin Heart EXCOR Pediatric Post Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Berlin Heart, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Berlin Heart, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether&#xD;
      safety and outcomes of the device use in the commercial setting are comparable to the safety&#xD;
      and outcomes of the device use in the IDE study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to cardiac&#xD;
      transplantation for pediatric patients. Pediatric candidates with severe isolated left&#xD;
      ventricular or biventricular dysfunction who are candidates for cardiac transplant and&#xD;
      require circulatory support may be treated using the EXCOR® Pediatric.&#xD;
&#xD;
      Study Purpose The purpose of this post-approval study of the EXCOR® Pediatric VAD is to&#xD;
      evaluate whether safety and outcomes of the device use in the commercial setting are&#xD;
      comparable to the safety and outcomes of the device use in the IDE study. Because the device&#xD;
      had extensive use (available to all North American sites who requested the device under&#xD;
      compassionate use regulations), it is expected that the pre-approval and post-approval use&#xD;
      will be similar.&#xD;
&#xD;
      The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to&#xD;
      demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR®&#xD;
      Pediatric in the study is not greater than the rate experienced in the IDE study.&#xD;
&#xD;
      The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to&#xD;
      assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible&#xD;
      children in need of mechanical circulatory support. Outcome is defined as transplant,&#xD;
      recovery of left ventricular function or death.&#xD;
&#xD;
      The following secondary objectives will be summarized:&#xD;
&#xD;
        -  Device Malfunction&#xD;
&#xD;
        -  Site evaluation of explanted pumps for suspected thrombus&#xD;
&#xD;
        -  Assessment of the learning curve&#xD;
&#xD;
      The study will be an &quot;all-comers&quot; prospective study maintained by the sponsor consisting of&#xD;
      pediatric patients aged 0-21 years implanted according to the IFU with the EXCOR® Pediatric&#xD;
      who are transplant eligible children in need of mechanical circulatory support and who&#xD;
      consent to be enrolled into the study.&#xD;
&#xD;
      The study will enroll at least 39 subjects implanted with the device per device labeling and&#xD;
      who consent to be enrolled into the post approval study after the study commencement at any&#xD;
      implanting site with IRB approval for participation.&#xD;
&#xD;
      Study enrollment is expected to take 10-12 months and subjects will be followed until they&#xD;
      reach an outcome. The primary endpoints will be analyzed and reported to FDA during the&#xD;
      regular reporting cycle. Explanted subjects will be followed for 24 months post explant. A&#xD;
      final report will be submitted to FDA once all subjects complete their 24 month post explant&#xD;
      visit. Average time on device is expected to be similar to the average time on the device&#xD;
      during the IDE study (58 days) therefore the last implant is expected to be followed until&#xD;
      outcome (IDE range was 0 - 435 days). The overall study duration is expected to be&#xD;
      approximately 36-38 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>2 years</time_frame>
    <description>The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR® Pediatric in the study is not greater than the rate experienced in the IDE study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>2 years</time_frame>
    <description>The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible children in need of mechanical circulatory support. Outcome is defined as transplant, recovery of left ventricular function or death.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">49</enrollment>
  <condition>Severe Isolated Left Ventricular Dysfunction</condition>
  <condition>Severe Biventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>EXCOR</arm_group_label>
    <description>Pediatric candidates age 0 - 21 with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR® Pediatric.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EXCOR Pediatric</intervention_name>
    <description>Ventricular Assist Device</description>
    <arm_group_label>EXCOR</arm_group_label>
    <other_name>EXCOR Pediatric VAD</other_name>
    <other_name>EXCOR Pediatric Ventricular Assist Device</other_name>
    <other_name>Berlin Heart EXCOR Pediatric</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be an &quot;all-comers&quot; prospective study including subjects whom meet the&#xD;
        Inclusion and Exclusion Criteria. Pediatric candidates with severe isolated left&#xD;
        ventricular or biventricular dysfunction who are candidates for cardiac transplant and&#xD;
        require circulatory support may be treated using the EXCOR® Pediatric.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient requires mechanical circulatory support and is eligible for cardiac&#xD;
             transplantation&#xD;
&#xD;
          -  Legal guardian and patient (if age appropriate) understands the nature of the implant&#xD;
             procedure and are willing to comply with associated follow-up evaluations, and provide&#xD;
             written informed consent and assent prior to the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is currently enrolled in EXCOR® Pediatric pre-market study&#xD;
&#xD;
          -  Patient is currently participating in another investigational device or drug trial&#xD;
             which would confound the results of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert M Kroslowitz, BS</last_name>
    <role>Study Director</role>
    <affiliation>Berlin Heart, Inc</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</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>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Left</mesh_term>
  </condition_browse>
  <!-- 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/NCT01674699
org study id: EXCOR PAS
secondary id: H100004
nct id: NCT01674699
lead sponsor: 
has dmc: No
The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether
      safety and outcomes of the device use in the commercial setting are comparable to the safety
      and outcomes of the device use in the IDE study.
EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to cardiac
      transplantation for pediatric patients. Pediatric candidates with severe isolated left
      ventricular or biventricular dysfunction who are candidates for cardiac transplant and
      require circulatory support may be treated using the EXCOR® Pediatric.

      Study Purpose The purpose of this post-approval study of the EXCOR® Pediatric VAD is to
      evaluate whether safety and outcomes of the device use in the commercial setting are
      comparable to the safety and outcomes of the device use in the IDE study. Because the device
      had extensive use (available to all North American sites who requested the device under
      compassionate use regulations), it is expected that the pre-approval and post-approval use
      will be similar.

      The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to
      demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR®
      Pediatric in the study is not greater than the rate experienced in the IDE study.

      The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to
      assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible
      children in need of mechanical circulatory support. Outcome is defined as transplant,
      recovery of left ventricular function or death.

      The following secondary objectives will be summarized:

        -  Device Malfunction

        -  Site evaluation of explanted pumps for suspected thrombus

        -  Assessment of the learning curve

      The study will be an "all-comers" prospective study maintained by the sponsor consisting of
      pediatric patients aged 0-21 years implanted according to the IFU with the EXCOR® Pediatric
      who are transplant eligible children in need of mechanical circulatory support and who
      consent to be enrolled into the study.

      The study will enroll at least 39 subjects implanted with the device per device labeling and
      who consent to be enrolled into the post approval study after the study commencement at any
      implanting site with IRB approval for participation.

      Study enrollment is expected to take 10-12 months and subjects will be followed until they
      reach an outcome. The primary endpoints will be analyzed and reported to FDA during the
      regular reporting cycle. Explanted subjects will be followed for 24 months post explant. A
      final report will be submitted to FDA once all subjects complete their 24 month post explant
      visit. Average time on device is expected to be similar to the average time on the device
      during the IDE study (58 days) therefore the last implant is expected to be followed until
      outcome (IDE range was 0 - 435 days). The overall study duration is expected to be
      approximately 36-38 months.
observational model: Cohort
time perspective: Prospective
measure: Safety
time frame: 2 years
description: The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR® Pediatric in the study is not greater than the rate experienced in the IDE study.
measure: Effectiveness
time frame: 2 years
description: The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible children in need of mechanical circulatory support. Outcome is defined as transplant, recovery of left ventricular function or death.
arm group label: EXCOR
description: Pediatric candidates age 0 - 21 with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR® Pediatric.
intervention type: Device
intervention name: EXCOR Pediatric
description: Ventricular Assist Device
arm group label: EXCOR
other name: EXCOR Pediatric VAD
other name: EXCOR Pediatric Ventricular Assist Device
other name: Berlin Heart EXCOR Pediatric
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 21 Years
healthy volunteers: No
last name: Robert M Kroslowitz, BS
role: Study Director
affiliation: Berlin Heart, Inc
responsible party type: Sponsor
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Left