<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/NCT04464785</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10336</org_study_id>
    <nct_id>NCT04464785</nct_id>
  </id_info>
  <brief_title>CentriMag Failure-to-Wean Post Approval Study</brief_title>
  <official_title>CentriMag Failure-to-Wean Post-Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this Post Approval Study is to report the proportion of patients&#xD;
      surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer.&#xD;
      For subjects who do not recover and are bridged to a heart transplant or a long-term assist&#xD;
      device, the primary endpoint is survival to induction of anesthesia for the surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Survival to 30 days Post CentriMag support or to hospital discharge</measure>
    <time_frame>30 days</time_frame>
    <description>The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival to induction of anesthesia for surgery for transplant or a long-term system</measure>
    <time_frame>Approximately 30 days</time_frame>
    <description>The proportion of subjects who do not recover and are bridged to a transplant or long-term system</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <description>Subjects who receive the CentriMag Circulatory Support System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CentriMag Circulatory Support System</intervention_name>
    <description>The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female subjects who fail-to-wean from cardiopulmonary bypass.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject &gt;18 years of age&#xD;
&#xD;
          -  Subject or legal representative has signed Informed Consent Form (ICF)&#xD;
&#xD;
          -  Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from&#xD;
             Cardiopulmonary Bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag&#xD;
        Circulatory Support System implantation due to FTW from CPB&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Ahmed</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hua-Wen Ding, MD, PhD</last_name>
    <phone>+32488151239</phone>
    <email>huawen.ding@abbott.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Baptist Healt Medical Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karol Mudy, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Hiesinger, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Advent Health Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Silvestry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antone Tatooles, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francis Pagani, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center Fairview</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Shaffer, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barnes Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muhammad Masood, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian/ Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koji Takeda, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Skipper, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Bermudez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Craig Selzman, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucian Durham, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</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>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04464785
org study id: ABT-CIP-10336
nct id: NCT04464785
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary objective of this Post Approval Study is to report the proportion of patients
      surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer.
      For subjects who do not recover and are bridged to a heart transplant or a long-term assist
      device, the primary endpoint is survival to induction of anesthesia for the surgery.
measure: Survival to 30 days Post CentriMag support or to hospital discharge
time frame: 30 days
description: The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
measure: Survival to induction of anesthesia for surgery for transplant or a long-term system
time frame: Approximately 30 days
description: The proportion of subjects who do not recover and are bridged to a transplant or long-term system
arm group label: Treatment
description: Subjects who receive the CentriMag Circulatory Support System
intervention type: Device
intervention name: CentriMag Circulatory Support System
description: The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.
arm group label: Treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara Ahmed
role: Study Director
affiliation: Abbott
last name: Hua-Wen Ding, MD, PhD
phone: +32488151239
email: huawen.ding@abbott.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No