<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/NCT04489914</url>
  </required_header>
  <id_info>
    <org_study_id>TAVI-STAR</org_study_id>
    <nct_id>NCT04489914</nct_id>
  </id_info>
  <brief_title>Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement</brief_title>
  <official_title>Observational Study on the Application of High-Flow Therapy in the Postinterventional Follow-up Care of Patients With Percutaneous Interventional Aortic Valve Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drägerwerk AG &amp; Co. KGaA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drägerwerk AG &amp; Co. KGaA</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>
      Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with&#xD;
      high perioperative risk has become a standard method in recent years. In addition to the&#xD;
      detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on&#xD;
      the monitoring of respiratory parameters after an operation under intubation anesthesia or&#xD;
      deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in&#xD;
      case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been&#xD;
      considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients&#xD;
      with a warmed and humidified air-oxygen mixture and to independently control the oxygen&#xD;
      content in the inhaled air and the flow in the pharyngeal area.&#xD;
&#xD;
      The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen&#xD;
      therapy as a measure of weaning success in postinterventional patients after TAVI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2020</start_date>
  <completion_date type="Actual">April 23, 2021</completion_date>
  <primary_completion_date type="Actual">April 23, 2021</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>Change of Horovitz index</measure>
    <time_frame>24 hours</time_frame>
    <description>The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis</description>
  </primary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Transcatheter Aortic Valve Replacement</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-Flow Oxygen Therapy</intervention_name>
    <description>high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        University hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High-flow oxygen therapy after TAVI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients without consent&#xD;
&#xD;
          -  age &lt; 18 years&#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>Tobias Graf, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Schleswig-Holstein</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04489914
org study id: TAVI-STAR
nct id: NCT04489914
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with
      high perioperative risk has become a standard method in recent years. In addition to the
      detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on
      the monitoring of respiratory parameters after an operation under intubation anesthesia or
      deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in
      case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been
      considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients
      with a warmed and humidified air-oxygen mixture and to independently control the oxygen
      content in the inhaled air and the flow in the pharyngeal area.

      The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen
      therapy as a measure of weaning success in postinterventional patients after TAVI.
observational model: Cohort
time perspective: Prospective
measure: Change of Horovitz index
time frame: 24 hours
description: The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis
intervention type: Device
intervention name: High-Flow Oxygen Therapy
description: high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tobias Graf, Dr
role: Principal Investigator
affiliation: University Hospital Schleswig-Holstein
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No