<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/NCT01672268</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A001113-38</org_study_id>
    <secondary_id>2011-A001113-38</secondary_id>
    <nct_id>NCT01672268</nct_id>
  </id_info>
  <brief_title>Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI</brief_title>
  <acronym>CT-TAVI</acronym>
  <official_title>Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People&#xD;
      with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter&#xD;
      aortic valve implantation (TAVI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is to show the interest of a cardiac computed tomography (CT) to improve&#xD;
      the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the&#xD;
      aortic annulus and help the physician to find the right position of the prosthesis during the&#xD;
      procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the&#xD;
      number of vascular peripheral complication, the number of stroke and can minimize the aortic&#xD;
      regurgitation during the follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite end point</measure>
    <time_frame>participants will be followed for the duration of 1 year</time_frame>
    <description>Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare results of transthoracic / transoesophageal echocardiography and cardiac CT</measure>
    <time_frame>inclusion visit</time_frame>
    <description>• Size of the aortic annulus/ diameter and area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare results of transthoracic / transoesophageal echocardiography and cardiac CT</measure>
    <time_frame>inclusion visit</time_frame>
    <description>• Left ventricular outflow tract, anatomy of the aortic roots</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare results of transthoracic / transoesophageal echocardiography and cardiac CT</measure>
    <time_frame>inclusion visit</time_frame>
    <description>• Left ventricular function, size, volume</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Standard TAVI procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients without Cardiac CT measures before TAVI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cardiac CT scan before TAVI procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with cardiac CT measures before TAVI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardiac computed tomography</intervention_name>
    <description>cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy</description>
    <arm_group_label>Cardiac CT scan before TAVI procedure</arm_group_label>
    <arm_group_label>Standard TAVI procedure</arm_group_label>
    <other_name>Transcatheter Aortic Valve Implantation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a symptomatic severe aortic stenosis with a too high risk of surgical&#xD;
             valvular replacement. This patient will be selected for a TAVI. In this study, we only&#xD;
             randomized patient for a TAVI with an Edwards prosthesis&#xD;
&#xD;
          -  male or female patient, older than eighteen years old&#xD;
&#xD;
          -  who have given their written consent&#xD;
&#xD;
          -  who are affiliated to the French social security system&#xD;
&#xD;
          -  which has a too high risk of surgical valvular replacement (EuroSCORE logistic &gt; 20%&#xD;
             or Society of Thoracic Surgeons Score &gt; 10, or contre indicated to a cardiac surgery&#xD;
             by a heart team&#xD;
&#xD;
          -  Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who can't give his written consent because of his physical or mental status&#xD;
&#xD;
          -  Adult patient protect by law (article L1121-8),&#xD;
&#xD;
          -  Person deprived of liberty (article L1121-8),&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient in terminal phase of illness,&#xD;
&#xD;
          -  Terminal kidney failure&#xD;
&#xD;
          -  Allergy to iodine&#xD;
&#xD;
          -  bicuspids ou unicuspid aortic,&#xD;
&#xD;
          -  Diameter of the left ventricular outflow tract &lt; 18mm or &gt; 25mm,&#xD;
&#xD;
          -  Diameter of the femoral artery &lt; 7mm, tortuosity or calcifications&#xD;
&#xD;
          -  Septal hypertrophy&#xD;
&#xD;
          -  Apical thrombosis.&#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>Gilles MD BARONE ROCHETTE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Grenoble</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2012</verification_date>
  <study_first_submitted>April 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>November 24, 2014</last_update_submitted>
  <last_update_submitted_qc>November 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac computed tomography</keyword>
  <keyword>Transcatheter Aortic Valve Implantation</keyword>
  <keyword>safety and efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</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/NCT01672268
org study id: 2011-A001113-38
secondary id: 2011-A001113-38
nct id: NCT01672268
lead sponsor: 
has dmc: Yes
This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People
      with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter
      aortic valve implantation (TAVI).
The proposed study is to show the interest of a cardiac computed tomography (CT) to improve
      the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the
      aortic annulus and help the physician to find the right position of the prosthesis during the
      procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the
      number of vascular peripheral complication, the number of stroke and can minimize the aortic
      regurgitation during the follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite end point
time frame: participants will be followed for the duration of 1 year
description: Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography
measure: To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
time frame: inclusion visit
description: • Size of the aortic annulus/ diameter and area
measure: To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
time frame: inclusion visit
description: • Left ventricular outflow tract, anatomy of the aortic roots
measure: To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
time frame: inclusion visit
description: • Left ventricular function, size, volume
arm group label: Standard TAVI procedure
arm group type: Active Comparator
description: Patients without Cardiac CT measures before TAVI
arm group label: Cardiac CT scan before TAVI procedure
arm group type: Experimental
description: patients with cardiac CT measures before TAVI
intervention type: Other
intervention name: cardiac computed tomography
description: cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
arm group label: Cardiac CT scan before TAVI procedure
arm group label: Standard TAVI procedure
other name: Transcatheter Aortic Valve Implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles MD BARONE ROCHETTE
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis