<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/NCT03247465</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0114</org_study_id>
    <nct_id>NCT03247465</nct_id>
  </id_info>
  <brief_title>Image Fusion and Calcification Raising in Trans Aortic Valve Implantation</brief_title>
  <acronym>TAVI</acronym>
  <official_title>Value of Fusion of 3D Images With 2D Images, Associated With Calcification Raising During Trans Aortic Valve Implantation Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve&#xD;
      implantation (TAVI) has been developed since 2002, first to treat rejected patients from&#xD;
      conventional surgery, then to treat high surgical risk patients and nowadays probably&#xD;
      intermediate surgical risk patient. TAVI related complications are still recurrent and the&#xD;
      investigators are searching a way to decrease them.&#xD;
&#xD;
      One of them could be image fusion, since it may decrease radiation exposure and contrast&#xD;
      agent use. It may also improve valve placement position leading to decreased complications.&#xD;
&#xD;
      40 prospective and consecutive patients will be included. Participants will be divided into&#xD;
      two groups: the 20 first included will be control group, the 20 following patients will be&#xD;
      the fusion group. For control group TAVI procedure will be the usual one, for fusion group&#xD;
      the procedure will be the usual one with addition of computed tomography 3D images fusion&#xD;
      with fluoroscopy 2D images.&#xD;
&#xD;
      Main evaluation criteria will be radiation exposure, measured by dose area product (DAP).&#xD;
      Secondary evaluation criterion will be procedural as contrast agent volume used, procedure&#xD;
      duration, subjective usefulness of image fusion or procedure failure evaluated immediately&#xD;
      after procedure. The investigators will also evaluated procedure induced complications as de&#xD;
      novo pacemaker implantation, de novo left bundle branch, vascular complication, major&#xD;
      bleeding, acute kidney failure, significant aortic regurgitation. These complications&#xD;
      occurrence will be evaluated after 1 month follow up, during the usual following&#xD;
      consultation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aortic stenosis is one of the most common cardiology diseases. If untreated, symptomatic&#xD;
      aortic stenosis rapidly leads to death. Most of the time, this disease affects old fragile&#xD;
      people for whom conventional surgery is countered or very risky. That is why Trans aortic&#xD;
      valve implantation has been developed since 2002, first to treat rejected patients from&#xD;
      conventional surgery, then to treat high surgical risk patients and nowadays probably&#xD;
      intermediate surgical risk patient. Indeed, thanks to prodigious technical and human&#xD;
      progress, procedure induced complication have clearly decreased. But TAVI related&#xD;
      complications are still recurrent and the investigators are searching a way to decrease them.&#xD;
&#xD;
      One of them could be image fusion, since it may decrease radiation exposure and contrast&#xD;
      agent use correlated to acute kidney failure. It may also improve valve placement position,&#xD;
      and the investigators know that many rhythmic (atrio-ventricular block) and valvular&#xD;
      (significant aortic regurgitation) complications are partially due to placement mistakes. So&#xD;
      the investigators hope that image fusion will decrease these complications.&#xD;
&#xD;
      The investigators will include 40 prospective and consecutive patients. Inclusion criterion&#xD;
      will be all major patients admitted in Nantes CHU for transfemoral aortic valve replacement&#xD;
      with SAPIEN® 3 valve. Exclusion criterion will be women of childbearing age without&#xD;
      contraception, impossible written consent, judiciary protected people. After inclusion,&#xD;
      patients will be divided into two groups: the 20 first included will be control group, the 20&#xD;
      following patients will be the fusion group. For control group TAVI procedure will be the&#xD;
      usual one, for fusion group the procedure will be the usual one with addition of computed&#xD;
      tomography 3D images fusion with fluoroscopy 2D images. The only difference during all&#xD;
      patient medical care will be the addition of image fusion in fusion group. Before and after&#xD;
      procedure, both groups will have the usual medical monitoring and the appropriated medical&#xD;
      interventions to participants case.&#xD;
&#xD;
      Main evaluation criterion will be radiation exposure, measured by dose area product (DAP).&#xD;
&#xD;
      Secondary evaluation criterion will be procedural as:&#xD;
&#xD;
        -  contrast agent volume used (mL),&#xD;
&#xD;
        -  procedure duration (min),&#xD;
&#xD;
        -  subjective usefulness of image fusion evaluated on a 0 to 3 scale&#xD;
&#xD;
        -  procedure failure : death, more than one valve implantation, valve dysfunction (mean&#xD;
           trans-valvular gradient &gt; 20 mmHg or moderate to severe aortic regurgitation) These&#xD;
           criterions will be evaluated immediately after procedure.&#xD;
&#xD;
      The investigators will also evaluated procedure induced complications as:&#xD;
&#xD;
        -  de novo pacemaker implantation&#xD;
&#xD;
        -  de novo left bundle branch&#xD;
&#xD;
        -  non minor vascular complication on VARC-2 definition&#xD;
&#xD;
        -  major bleeding (BARC 3 or 5)&#xD;
&#xD;
        -  acute kidney failure (AKIN 2 or 3)&#xD;
&#xD;
        -  significant aortic regurgitation ≥ 2/4 These complications occurrence will be evaluated&#xD;
           after 1 month follow up, during the usual following consultation with echocardiography.&#xD;
&#xD;
      Then differences between will be tested with appropriated statistical methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The deadlines of the ethics committee being very long, the investigator finally wished not to&#xD;
    carry out the project.&#xD;
  </why_stopped>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">September 13, 2017</completion_date>
  <primary_completion_date type="Actual">September 13, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The 20 first included patients will be control group, the 20 following patients will be the fusion group.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation exposure</measure>
    <time_frame>Immediately post procedure</time_frame>
    <description>Dose area product (cGy/cm2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast product</measure>
    <time_frame>Immediately post procedure</time_frame>
    <description>Contrast volume (mL) used during procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Symptomatic Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Group &quot;Fusion&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trans aortic valve replacement with usual procedure with the addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group &quot;Control&quot;</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Trans aortic valve replacement with usual procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Image Fusion</intervention_name>
    <description>Addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.</description>
    <arm_group_label>Group &quot;Fusion&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted in Nantes CHU for trans fermoral aortic valve replacement with&#xD;
             SAPIEN 3® device&#xD;
&#xD;
          -  Patient who accepted to participate to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossible written consent&#xD;
&#xD;
          -  Judiciary protected people&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Women of childbearing age without contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2021</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>Aortic Valve Stenosis</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/NCT03247465
org study id: RC17_0114
nct id: NCT03247465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve
      implantation (TAVI) has been developed since 2002, first to treat rejected patients from
      conventional surgery, then to treat high surgical risk patients and nowadays probably
      intermediate surgical risk patient. TAVI related complications are still recurrent and the
      investigators are searching a way to decrease them.

      One of them could be image fusion, since it may decrease radiation exposure and contrast
      agent use. It may also improve valve placement position leading to decreased complications.

      40 prospective and consecutive patients will be included. Participants will be divided into
      two groups: the 20 first included will be control group, the 20 following patients will be
      the fusion group. For control group TAVI procedure will be the usual one, for fusion group
      the procedure will be the usual one with addition of computed tomography 3D images fusion
      with fluoroscopy 2D images.

      Main evaluation criteria will be radiation exposure, measured by dose area product (DAP).
      Secondary evaluation criterion will be procedural as contrast agent volume used, procedure
      duration, subjective usefulness of image fusion or procedure failure evaluated immediately
      after procedure. The investigators will also evaluated procedure induced complications as de
      novo pacemaker implantation, de novo left bundle branch, vascular complication, major
      bleeding, acute kidney failure, significant aortic regurgitation. These complications
      occurrence will be evaluated after 1 month follow up, during the usual following
      consultation.
Aortic stenosis is one of the most common cardiology diseases. If untreated, symptomatic
      aortic stenosis rapidly leads to death. Most of the time, this disease affects old fragile
      people for whom conventional surgery is countered or very risky. That is why Trans aortic
      valve implantation has been developed since 2002, first to treat rejected patients from
      conventional surgery, then to treat high surgical risk patients and nowadays probably
      intermediate surgical risk patient. Indeed, thanks to prodigious technical and human
      progress, procedure induced complication have clearly decreased. But TAVI related
      complications are still recurrent and the investigators are searching a way to decrease them.

      One of them could be image fusion, since it may decrease radiation exposure and contrast
      agent use correlated to acute kidney failure. It may also improve valve placement position,
      and the investigators know that many rhythmic (atrio-ventricular block) and valvular
      (significant aortic regurgitation) complications are partially due to placement mistakes. So
      the investigators hope that image fusion will decrease these complications.

      The investigators will include 40 prospective and consecutive patients. Inclusion criterion
      will be all major patients admitted in Nantes CHU for transfemoral aortic valve replacement
      with SAPIEN® 3 valve. Exclusion criterion will be women of childbearing age without
      contraception, impossible written consent, judiciary protected people. After inclusion,
      patients will be divided into two groups: the 20 first included will be control group, the 20
      following patients will be the fusion group. For control group TAVI procedure will be the
      usual one, for fusion group the procedure will be the usual one with addition of computed
      tomography 3D images fusion with fluoroscopy 2D images. The only difference during all
      patient medical care will be the addition of image fusion in fusion group. Before and after
      procedure, both groups will have the usual medical monitoring and the appropriated medical
      interventions to participants case.

      Main evaluation criterion will be radiation exposure, measured by dose area product (DAP).

      Secondary evaluation criterion will be procedural as:

        -  contrast agent volume used (mL),

        -  procedure duration (min),

        -  subjective usefulness of image fusion evaluated on a 0 to 3 scale

        -  procedure failure : death, more than one valve implantation, valve dysfunction (mean
           trans-valvular gradient > 20 mmHg or moderate to severe aortic regurgitation) These
           criterions will be evaluated immediately after procedure.

      The investigators will also evaluated procedure induced complications as:

        -  de novo pacemaker implantation

        -  de novo left bundle branch

        -  non minor vascular complication on VARC-2 definition

        -  major bleeding (BARC 3 or 5)

        -  acute kidney failure (AKIN 2 or 3)

        -  significant aortic regurgitation ≥ 2/4 These complications occurrence will be evaluated
           after 1 month follow up, during the usual following consultation with echocardiography.

      Then differences between will be tested with appropriated statistical methods.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The 20 first included patients will be control group, the 20 following patients will be the fusion group.
primary purpose: Other
masking: None (Open Label)
measure: Radiation exposure
time frame: Immediately post procedure
description: Dose area product (cGy/cm2)
measure: Contrast product
time frame: Immediately post procedure
description: Contrast volume (mL) used during procedure
arm group label: Group "Fusion"
arm group type: Experimental
description: Trans aortic valve replacement with usual procedure with the addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.
arm group label: Group "Control"
arm group type: No Intervention
description: Trans aortic valve replacement with usual procedure
intervention type: Other
intervention name: Image Fusion
description: Addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.
arm group label: Group "Fusion"
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No