<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/NCT04464356</url>
  </required_header>
  <id_info>
    <org_study_id>2020-380</org_study_id>
    <nct_id>NCT04464356</nct_id>
  </id_info>
  <brief_title>Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients</brief_title>
  <official_title>Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To explore the experience of transcranial aortic valve replacement (TAVR) under&#xD;
      emergency mechanical assisted circulation (MCS).Methods: A total of 6 patients who completed&#xD;
      TAVR with the assistance of emergency MCS in the Second Affiliated Hospital of Zhejiang&#xD;
      University School of Medicine from March 2013 to June 2019 were retrospectively analyzed.The&#xD;
      management of perioperative mechanical assisted circulation, preoperative evaluation,&#xD;
      intraoperative operation and postoperative situation of patients were summarized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>30-Day mortality rate</measure>
    <time_frame>30 days after TAVR procedure</time_frame>
    <description>30-Day mortality rate</description>
  </primary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Transcatheter Aortic Valve Replacement</condition>
  <condition>Mechanical Circulatory Support</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mechanical circulatory support</intervention_name>
    <description>mechanical circulatory support: cardiopulmonary bypass, extracorporeal membrane oxygenation(ECMO), left ventricular assist device</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients assisted by emergency peripheral MCS during TAVR due to circulatory collapse.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TAVR patient, assisted by emergency peripheral MCS due to circulatory collapse during&#xD;
             TAVR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients presented mechanical complications such as massive hemorrhage, coronary&#xD;
             artery occlusion or left ventricular rupture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transcatheter aortic valve replacement</keyword>
  <keyword>mechanical circulatory support</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>,extracorporeal membranous oxygenator</keyword>
  <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/NCT04464356
org study id: 2020-380
nct id: NCT04464356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To explore the experience of transcranial aortic valve replacement (TAVR) under
      emergency mechanical assisted circulation (MCS).Methods: A total of 6 patients who completed
      TAVR with the assistance of emergency MCS in the Second Affiliated Hospital of Zhejiang
      University School of Medicine from March 2013 to June 2019 were retrospectively analyzed.The
      management of perioperative mechanical assisted circulation, preoperative evaluation,
      intraoperative operation and postoperative situation of patients were summarized.
observational model: Case-Only
time perspective: Retrospective
measure: 30-Day mortality rate
time frame: 30 days after TAVR procedure
description: 30-Day mortality rate
intervention type: Device
intervention name: mechanical circulatory support
description: mechanical circulatory support: cardiopulmonary bypass, extracorporeal membrane oxygenation(ECMO), left ventricular assist device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No