<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/NCT03831048</url>
  </required_header>
  <id_info>
    <org_study_id>OCS-CAR-03202019</org_study_id>
    <nct_id>NCT03831048</nct_id>
  </id_info>
  <brief_title>Donors After Circulatory Death Heart Trial</brief_title>
  <official_title>Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TransMedics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TransMedics</source>
  <oversight_info>
    <has_dmc>Yes</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 evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess&#xD;
      hearts donated after circulatory death for transplantation to increase the pool of donor&#xD;
      hearts available for transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which&#xD;
      subjects who receive a DCD donor heart transplant will be compared to subjects who receive a&#xD;
      standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2&#xD;
      [SOC2] - from both randomized and concurrent control groups), adjusting for differences in&#xD;
      risk factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2019</start_date>
  <completion_date type="Actual">September 28, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>6 months</time_frame>
    <description>Patient survival 6 months post-transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Utilization rate</measure>
    <time_frame>Within 24 hours post-transplant</time_frame>
    <description>Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient and graft survival</measure>
    <time_frame>30 days</time_frame>
    <description>Patient and graft survival at 30 days post transplant</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient and graft survival</measure>
    <time_frame>30 days or hospital discharge, if later than 30 days</time_frame>
    <description>Patient and graft survival at 30 days and initial hospital discharge, if later than 30 days</description>
  </other_outcome>
  <other_outcome>
    <measure>Severe heart primary graft dysfunction</measure>
    <time_frame>24 hours post transplant</time_frame>
    <description>Severe heart primary graft dysfunction of the left and/or right ventricle, not including rejection of cardiac tamponade</description>
  </other_outcome>
  <other_outcome>
    <measure>Post transplant Mechanical Circulatory Support (MCS)</measure>
    <time_frame>&gt;72 hours immediately post-transplant</time_frame>
    <description>Use of post-transplant mechanical circulatory support (LVAD, RVAD, BiVAD) for &gt; 72 hours immediately post-transplant.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient survival at 1 year after transplant (collected post-approval)</measure>
    <time_frame>One year post-transplant.</time_frame>
    <description>Patient survival at 1 year after transplant (collected post-approval); comparison of DCD Heart Transplanted Recipients and SOC Heart Transplant Recipients (SOC1 + SOC2) through UNOS/OPTN database.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Heart Transplant</condition>
  <arm_group>
    <arm_group_label>DCD Heart Possible</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Heart Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCS Heart System</intervention_name>
    <description>Preserving and assessing donor after circulatory death hearts for transplant</description>
    <arm_group_label>DCD Heart Possible</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold Storage</intervention_name>
    <description>Active comparator intervention</description>
    <arm_group_label>Standard of Care Heart Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Donor Inclusion&#xD;
&#xD;
          -  Maastricht Category III DCD donor, defined as expected death after the withdrawal of&#xD;
             life- supportive therapy (WLST)&#xD;
&#xD;
          -  Donor age 18-49 years old inclusive&#xD;
&#xD;
          -  Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when&#xD;
             mean systolic blood pressure (SBP) is &lt; 50 mmHg or peripheral saturation &lt; 70% to&#xD;
             aortic cross-clamp and administration of cold cardioplegia in the donor.&#xD;
&#xD;
        Donor Exclusion&#xD;
&#xD;
          -  Previous cardiac surgery&#xD;
&#xD;
          -  Known coronary artery disease&#xD;
&#xD;
          -  Cardiogenic shock or myocardial infarction, or&#xD;
&#xD;
          -  Sustained terminal ejection fraction (EF) of ≤ 50%, or&#xD;
&#xD;
          -  Significant valve disease except for competent bicuspid aortic valve&#xD;
&#xD;
        Recipient Inclusion&#xD;
&#xD;
          -  Primary heart transplant candidates&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Signed: (1) written informed consent document; (2) authorization to use and disclose&#xD;
             protected health information; and (3) consent to TransMedics' use of recipients'&#xD;
             United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network&#xD;
             (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory&#xD;
             Support (INTERMACS) data.&#xD;
&#xD;
        Recipient Exclusion&#xD;
&#xD;
          -  Prior solid organ or bone marrow transplant&#xD;
&#xD;
          -  Chronic use of hemodialysis or diagnosis of chronic renal insufficiency&#xD;
&#xD;
          -  Multi-organ transplant&#xD;
&#xD;
          -  Investigator unwilling to randomize to either arm.&#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>University of California San Diago</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Cardiovascular Research Institute</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nyph/Cumc</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virgina Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert &amp; the Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart preservation</keyword>
  <keyword>Beating heart transplant</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/NCT03831048
org study id: OCS-CAR-03202019
nct id: NCT03831048
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess
      hearts donated after circulatory death for transplantation to increase the pool of donor
      hearts available for transplantation.
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which
      subjects who receive a DCD donor heart transplant will be compared to subjects who receive a
      standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2
      [SOC2] - from both randomized and concurrent control groups), adjusting for differences in
      risk factors.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 6 months
description: Patient survival 6 months post-transplant
measure: Utilization rate
time frame: Within 24 hours post-transplant
description: Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.
measure: Patient and graft survival
time frame: 30 days
description: Patient and graft survival at 30 days post transplant
measure: Patient and graft survival
time frame: 30 days or hospital discharge, if later than 30 days
description: Patient and graft survival at 30 days and initial hospital discharge, if later than 30 days
measure: Severe heart primary graft dysfunction
time frame: 24 hours post transplant
description: Severe heart primary graft dysfunction of the left and/or right ventricle, not including rejection of cardiac tamponade
measure: Post transplant Mechanical Circulatory Support (MCS)
time frame: >72 hours immediately post-transplant
description: Use of post-transplant mechanical circulatory support (LVAD, RVAD, BiVAD) for > 72 hours immediately post-transplant.
measure: Patient survival at 1 year after transplant (collected post-approval)
time frame: One year post-transplant.
description: Patient survival at 1 year after transplant (collected post-approval); comparison of DCD Heart Transplanted Recipients and SOC Heart Transplant Recipients (SOC1 + SOC2) through UNOS/OPTN database.
arm group label: DCD Heart Possible
arm group type: Experimental
arm group label: Standard of Care Heart Only
arm group type: Active Comparator
intervention type: Device
intervention name: OCS Heart System
description: Preserving and assessing donor after circulatory death hearts for transplant
arm group label: DCD Heart Possible
intervention type: Other
intervention name: Cold Storage
description: Active comparator intervention
arm group label: Standard of Care Heart Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor