<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/NCT01727310</url>
  </required_header>
  <id_info>
    <org_study_id>I10013</org_study_id>
    <nct_id>NCT01727310</nct_id>
  </id_info>
  <brief_title>Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis</brief_title>
  <acronym>PRESSEVAL</acronym>
  <official_title>Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Left valvular heart disease has become one of the most common heart disease in Western&#xD;
      countries. This disease evolve over many years and are characterized by a long phase where&#xD;
      the patient is &quot;asymptomatic&quot;.&#xD;
&#xD;
      it is characterized by discomfort LV filling may worsen and lead typically to a pressure&#xD;
      increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable&#xD;
      and may occur at the stage of diastolic or systolic dysfunction.&#xD;
&#xD;
      Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing&#xD;
      that it is often very difficult to know if the patient is actually symptomatic. The onset of&#xD;
      symptoms sign an intolerance to the increase in LV filling pressures and LA , causing&#xD;
      pulmonary hypertension .&#xD;
&#xD;
      Therefore, the study of the level of LV and LA filling pressures , if possible by a&#xD;
      noninvasive method, would identify patients apparently asymptomatic even though their&#xD;
      condition is advanced.&#xD;
&#xD;
      Pressures filling pressures can be explored by two methods:&#xD;
&#xD;
        -  cardiac catheterization, which is a direct and invasive measurement method&#xD;
&#xD;
        -  echocardiography, which is an indirect measurement method which has the advantage of&#xD;
           being non-invasive The goal of this research is to compare the two methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>quality of echocardiography</measure>
    <description>Evaluate the diagnostic quality of echocardiography to measure the volume of the LA indexed to body surface area compared to cardiac catheterization</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Valvular Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of both gender hospitalized for a coarctation review, and has received or will be&#xD;
        receiving during their stay a complete echocardiography and coronary angiography, and left&#xD;
        and right catheterization .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years;&#xD;
&#xD;
          -  Patients hospitalized for a coarctation review, and has received or will be receiving&#xD;
             during their stay a complete echocardiography and coronary angiography, and left and&#xD;
             right catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with a history of valve replacement surgery,&#xD;
&#xD;
          -  Patients with other valvular&gt; grade 2 associated with the coarctation&#xD;
&#xD;
          -  Patients known to have ischemic heart disease or in whom angiography showed&#xD;
             significant coronary artery disease;&#xD;
&#xD;
          -  Patients with chronic or paroxysmal atrial fibrillation&#xD;
&#xD;
          -  Patients with a permanently pacemaker&#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>Departement de Cardiologie</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departement de Cardiologie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>May 24, 2014</last_update_submitted>
  <last_update_submitted_qc>May 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</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>
  <!-- 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/NCT01727310
org study id: I10013
nct id: NCT01727310
lead sponsor: 
has dmc: No
Left valvular heart disease has become one of the most common heart disease in Western
      countries. This disease evolve over many years and are characterized by a long phase where
      the patient is "asymptomatic".

      it is characterized by discomfort LV filling may worsen and lead typically to a pressure
      increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable
      and may occur at the stage of diastolic or systolic dysfunction.

      Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing
      that it is often very difficult to know if the patient is actually symptomatic. The onset of
      symptoms sign an intolerance to the increase in LV filling pressures and LA , causing
      pulmonary hypertension .

      Therefore, the study of the level of LV and LA filling pressures , if possible by a
      noninvasive method, would identify patients apparently asymptomatic even though their
      condition is advanced.

      Pressures filling pressures can be explored by two methods:

        -  cardiac catheterization, which is a direct and invasive measurement method

        -  echocardiography, which is an indirect measurement method which has the advantage of
           being non-invasive The goal of this research is to compare the two methods.
observational model: Case-Only
measure: quality of echocardiography
description: Evaluate the diagnostic quality of echocardiography to measure the volume of the LA indexed to body surface area compared to cardiac catheterization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis