<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/NCT03248232</url>
  </required_header>
  <id_info>
    <org_study_id>Ethics No. 1440</org_study_id>
    <nct_id>NCT03248232</nct_id>
  </id_info>
  <brief_title>Assessments of Thrombus Formation in TAVI</brief_title>
  <official_title>AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kumamoto University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kumamoto 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>
      Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical&#xD;
      outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high&#xD;
      surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI&#xD;
      compared to those in surgical aortic valve replacement, those in TAVI still remains high. In&#xD;
      addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus&#xD;
      aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach.&#xD;
      The antithrombotic regimen in patients undergoing TAVI is needed to be established.&#xD;
&#xD;
      To establish the antithrombotic regimen in patients undergoing TAVI,&#xD;
&#xD;
        1. the investigators assess the changes in platelet thrombus formation and white thrombus&#xD;
           formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis&#xD;
           System (T-TAS).&#xD;
&#xD;
        2. the investigators analyze plasma microRNAs, and shear stress by using computational&#xD;
           fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI</measure>
    <time_frame>pre-, day 2, day 7, 1 month after device implantation</time_frame>
    <description>To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT</measure>
    <time_frame>pre-, day 7 after device implantation</time_frame>
    <description>To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in von Willebrand factor multimer decrease</measure>
    <time_frame>pre-, day 2 after device implantation</time_frame>
    <description>To measure the von Willebrand factor multimer decrease by using electrophoresis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.</measure>
    <time_frame>within 30 days after device implantation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in plasma microRNAs</measure>
    <time_frame>pre-, day 2 after device implantation</time_frame>
    <description>To measure the expression of plasma microRNAs before and after TAVI by using qPCR.</description>
  </other_outcome>
  <enrollment type="Actual">23</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Heart Valve Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic&#xD;
        valve implantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  twenty years and older&#xD;
&#xD;
          -  with the informed consent of the patient or support person in case of disability at&#xD;
             baseline (patient intubated and ventilated)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  withdrawn the informed consent&#xD;
&#xD;
          -  patients with trans-apical approach&#xD;
&#xD;
          -  critical illness condition (severe infectious disease, cancer, severe bleeding&#xD;
             disorder)&#xD;
&#xD;
          -  transition to the surgical AVR&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 30, 2018</last_update_submitted>
  <last_update_submitted_qc>September 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kumamoto University</investigator_affiliation>
    <investigator_full_name>Kenichi Tsujita, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Cardiovascular Medicine, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transcatheter aortic valve implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03248232
org study id: Ethics No. 1440
nct id: NCT03248232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical
      outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high
      surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI
      compared to those in surgical aortic valve replacement, those in TAVI still remains high. In
      addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus
      aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach.
      The antithrombotic regimen in patients undergoing TAVI is needed to be established.

      To establish the antithrombotic regimen in patients undergoing TAVI,

        1. the investigators assess the changes in platelet thrombus formation and white thrombus
           formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis
           System (T-TAS).

        2. the investigators analyze plasma microRNAs, and shear stress by using computational
           fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.
observational model: Cohort
time perspective: Prospective
measure: Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
time frame: pre-, day 2, day 7, 1 month after device implantation
description: To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.
measure: Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT
time frame: pre-, day 7 after device implantation
description: To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).
measure: Changes in von Willebrand factor multimer decrease
time frame: pre-, day 2 after device implantation
description: To measure the von Willebrand factor multimer decrease by using electrophoresis
measure: Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.
time frame: within 30 days after device implantation
measure: Changes in plasma microRNAs
time frame: pre-, day 2 after device implantation
description: To measure the expression of plasma microRNAs before and after TAVI by using qPCR.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kumamoto University
investigator full name: Kenichi Tsujita, MD, PhD
investigator title: Professor of Cardiovascular Medicine, Principal Investigator
mesh term: Aortic Valve Stenosis
mesh term: Heart Valve Diseases