<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/NCT03298932</url>
  </required_header>
  <id_info>
    <org_study_id>9597</org_study_id>
    <nct_id>NCT03298932</nct_id>
  </id_info>
  <brief_title>2D Strain of Right Ventricle in Peroperative of Cardiac Surgery</brief_title>
  <official_title>2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics&#xD;
      obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .&#xD;
&#xD;
      TEE is performed for each patient of cardiac surgery during the operation time .&#xD;
&#xD;
      This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction&#xD;
      after cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac&#xD;
      surgery :&#xD;
&#xD;
      In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic&#xD;
      valve surgery without coronary diseases or previous RV dysfunction.&#xD;
&#xD;
      Comparison with others echocardiographic parameters of RV evaluation Association with right&#xD;
      ventricle insufficiency after cardiac surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2016</start_date>
  <completion_date type="Actual">June 7, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>2D strain modification of right ventricle after cardiac surgery</measure>
    <time_frame>up to 24 hours</time_frame>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Aortic Valve Disorder</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aortic valve surgery</intervention_name>
    <description>Aortic valve surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient eligible for aortic valve surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient eligible for aortic valve surgery&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  previous right ventricle dysfunction&#xD;
&#xD;
          -  severe coronary disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Géraldine CULAS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Arnaud de Villeneuve réanimation</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>March 27, 2018</last_update_submitted>
  <last_update_submitted_qc>March 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transesophageal echography</keyword>
  <keyword>Perioperative cardiac surgery</keyword>
  <keyword>Aortic valve replacement</keyword>
  <keyword>2D strain of right ventricle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03298932
org study id: 9597
nct id: NCT03298932
lead sponsor: 
has dmc: Yes
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics
      obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .

      TEE is performed for each patient of cardiac surgery during the operation time .

      This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction
      after cardiac surgery.
Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac
      surgery :

      In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic
      valve surgery without coronary diseases or previous RV dysfunction.

      Comparison with others echocardiographic parameters of RV evaluation Association with right
      ventricle insufficiency after cardiac surgery.
observational model: Case-Only
time perspective: Prospective
measure: 2D strain modification of right ventricle after cardiac surgery
time frame: up to 24 hours
intervention type: Procedure
intervention name: Aortic valve surgery
description: Aortic valve surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Géraldine CULAS, MD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Aortic Valve Disease
sharing ipd: Undecided