<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/NCT03835754</url>
  </required_header>
  <id_info>
    <org_study_id>OCS-CAR-121918</org_study_id>
    <nct_id>NCT03835754</nct_id>
  </id_info>
  <brief_title>Heart EXPAND Continued Access Protocol</brief_title>
  <official_title>Heart Expand Continued Access Protocol</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>
      The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet&#xD;
      current standard donor heart acceptance criteria for transplantation in this continued access&#xD;
      protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System&#xD;
      to preserve and assess donor hearts that do not meet current standard donor heart acceptance&#xD;
      criteria (as identified above) for transplantation to potentially improve donor heart&#xD;
      utilization for transplantation at a range of transplant centers in the U.S. and to permit&#xD;
      patients and physicians access to the OCS Heart System while a PMA application is under&#xD;
      preparation and review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Actual">August 12, 2022</completion_date>
  <primary_completion_date type="Actual">September 15, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>30 days</time_frame>
    <description>Patient survival post transplant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of severe PGD</measure>
    <time_frame>24 hours post heart transplant</time_frame>
    <description>Absence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>30 days</time_frame>
    <description>Patient and graft survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of severe PGD</measure>
    <time_frame>24 hours post transplant</time_frame>
    <description>Incidence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post heart transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Donor heart utilization rate</measure>
    <time_frame>24 hours post-transplant</time_frame>
    <description>The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Survival</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Patient survival at 6 and 12 months post-transplant</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of primary graft failure</measure>
    <time_frame>Through 12 months post transplant</time_frame>
    <description>Incidence of primary graft failure requiring re-transplantation</description>
  </other_outcome>
  <other_outcome>
    <measure>ICU stay</measure>
    <time_frame>Through hospital discharge, estimated to be 14 days</time_frame>
    <description>Duration of initial post-transplant ICU stay in days</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Through hospital discharge, estimated to be 30 days</time_frame>
    <description>Duration of initial post-transplant hospital stay in days</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Heart Transplant</condition>
  <arm_group>
    <arm_group_label>OCS Preservation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCS Heart System</intervention_name>
    <description>The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment</description>
    <arm_group_label>OCS Preservation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (DONOR):&#xD;
&#xD;
        At least one of the following:&#xD;
&#xD;
          -  Expected total cross-clamp time of ≥ 4 hours&#xD;
&#xD;
          -  Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk&#xD;
             factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or&#xD;
             Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of &gt;12&#xD;
             mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time&#xD;
             of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of&#xD;
             acceptance of offer; or Donor angiogram with luminal irregularities with no&#xD;
             significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac&#xD;
             function at time of donor assessment; or Social history of alcoholism with good&#xD;
             cardiac function at time of donor assessment; or History of diabetes without&#xD;
             significant CAD (≤ 50%) on angiogram.&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  CAD with &gt; 50% stenosis on angiogram, or&#xD;
&#xD;
          -  Cardiogenic shock or myocardial infarction, or&#xD;
&#xD;
          -  EF consistently &lt; 40%, or&#xD;
&#xD;
          -  Significant valve disease except for competent bicuspid aortic valve.&#xD;
&#xD;
        Eligibility Criteria (RECIPIENT)&#xD;
&#xD;
          -  Registered primary heart transplant candidate&#xD;
&#xD;
          -  Age &gt;18 years old&#xD;
&#xD;
          -  Written informed consent. Exclusion&#xD;
&#xD;
          -  Prior solid organ or bone marrow transplant&#xD;
&#xD;
          -  Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic&#xD;
             renal insufficiency requiring dialysis&#xD;
&#xD;
          -  Multi-organ transplant.&#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>Cedars-Sinai</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90211</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>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</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>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</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>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>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</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 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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/NCT03835754
org study id: OCS-CAR-121918
nct id: NCT03835754
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet
      current standard donor heart acceptance criteria for transplantation in this continued access
      protocol.
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System
      to preserve and assess donor hearts that do not meet current standard donor heart acceptance
      criteria (as identified above) for transplantation to potentially improve donor heart
      utilization for transplantation at a range of transplant centers in the U.S. and to permit
      patients and physicians access to the OCS Heart System while a PMA application is under
      preparation and review.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 30 days
description: Patient survival post transplant
measure: Absence of severe PGD
time frame: 24 hours post heart transplant
description: Absence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post transplant
measure: Survival
time frame: 30 days
description: Patient and graft survival
measure: Incidence of severe PGD
time frame: 24 hours post transplant
description: Incidence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post heart transplant
measure: Donor heart utilization rate
time frame: 24 hours post-transplant
description: The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System
measure: Survival
time frame: 6 and 12 months
description: Patient survival at 6 and 12 months post-transplant
measure: Incidence of primary graft failure
time frame: Through 12 months post transplant
description: Incidence of primary graft failure requiring re-transplantation
measure: ICU stay
time frame: Through hospital discharge, estimated to be 14 days
description: Duration of initial post-transplant ICU stay in days
measure: Hospital stay
time frame: Through hospital discharge, estimated to be 30 days
description: Duration of initial post-transplant hospital stay in days
arm group label: OCS Preservation
arm group type: Experimental
intervention type: Device
intervention name: OCS Heart System
description: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
arm group label: OCS Preservation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor