<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/NCT02986633</url>
  </required_header>
  <id_info>
    <org_study_id>OBS-009</org_study_id>
    <nct_id>NCT02986633</nct_id>
  </id_info>
  <brief_title>Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)</brief_title>
  <acronym>Echo-CRT</acronym>
  <official_title>Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present observational prospective study aims at identifying echocardiographic parameters&#xD;
      (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV)&#xD;
      ascertained using new methods of echocardiography including speckle tracking strain) that are&#xD;
      linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure&#xD;
      and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse&#xD;
      remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these&#xD;
      patients will not experience LV reverse remodelling following CRT.&#xD;
&#xD;
      Classical parameters of dyssynchrony obtained by conventional methods of echocardiography&#xD;
      (including doppler tissue imaging) have a limited value in predicting CRT response.&#xD;
      Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram&#xD;
      experience more frequently LV reverse remodelling than those without a LBBB.&#xD;
&#xD;
      LBBB is responsible for specific LV contractile abnormalities that can be identified by&#xD;
      speckle tracking strain echocardiography (early septal contraction, stretching of late&#xD;
      contraction of the postero-lateral wall). The predictive value of these abnormalities remains&#xD;
      to be studied.&#xD;
&#xD;
      Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be&#xD;
      independent predictors of LV reverse remodelling and outcome following CRT.&#xD;
&#xD;
      The present observational prospective study aims at identifying echocardiographic parameters&#xD;
      (based on the LBBB-like contraction of the LV ascertained using new methods of&#xD;
      echocardiography including speckle tracking strain) that are linked to CRT response and a&#xD;
      better outcome following CRT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Changes in left ventricular end-systolic volume measured by echocardiography</measure>
    <time_frame>9 months after implantation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death rate</measure>
    <time_frame>2, 4, 6, 8 and 10 years after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>re-hospitalisation rate</measure>
    <time_frame>2, 4, 6, 8 and 10 years after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in left ventricular ejection fraction measured by echocardiography</measure>
    <time_frame>9 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in left ventricular end-diastolic volume measured by echocardiography</measure>
    <time_frame>9 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in left ventricular longitudinal strain measured by echocardiography</measure>
    <time_frame>9 months after implantation</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Resynchronization Therapy</condition>
  <arm_group>
    <arm_group_label>Patients with heart failure and CRT</arm_group_label>
    <description>Heart failure with left ventricular ejection fraction less than 35 % treated with CRT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <arm_group_label>Patients with heart failure and CRT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with LV systolic dysfunction and QRS duration &gt; 120 ms receiving CRT at GHICL.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart failure with left ventricular ejection fraction less than 35 %&#xD;
&#xD;
          -  QRS duration over than 120 ms&#xD;
&#xD;
          -  Clinical indication for CRT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rythmologic indication of CRT for atrial fibrillation control&#xD;
&#xD;
          -  Rythmologic indication of CRT for left ventricular ejection fraction between 35% and&#xD;
             45%&#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>Sylvestre Maréchaux, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of Lille Catholic University (GHICL)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amélie Lansiaux, MD, PhD</last_name>
    <phone>00 33 3 20 52 69</phone>
    <email>lansiaux.amelie@ghicl.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospitals of Lille Catholic University (GHICL)</name>
      <address>
        <city>Lomme</city>
        <zip>59462</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amélie Lansiaux, MD, PhD</last_name>
      <phone>00 33 3 20 52 69</phone>
      <email>lansiaux.amelie@ghicl.net</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>July 18, 2018</last_update_submitted>
  <last_update_submitted_qc>July 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Resynchronization Therapy</keyword>
  <keyword>Echocardiography</keyword>
  <keyword>Biventricular Pacing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT02986633
org study id: OBS-009
nct id: NCT02986633
lead sponsor: 
has dmc: No
The present observational prospective study aims at identifying echocardiographic parameters
      (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV)
      ascertained using new methods of echocardiography including speckle tracking strain) that are
      linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT
The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure
      and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse
      remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these
      patients will not experience LV reverse remodelling following CRT.

      Classical parameters of dyssynchrony obtained by conventional methods of echocardiography
      (including doppler tissue imaging) have a limited value in predicting CRT response.
      Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram
      experience more frequently LV reverse remodelling than those without a LBBB.

      LBBB is responsible for specific LV contractile abnormalities that can be identified by
      speckle tracking strain echocardiography (early septal contraction, stretching of late
      contraction of the postero-lateral wall). The predictive value of these abnormalities remains
      to be studied.

      Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be
      independent predictors of LV reverse remodelling and outcome following CRT.

      The present observational prospective study aims at identifying echocardiographic parameters
      (based on the LBBB-like contraction of the LV ascertained using new methods of
      echocardiography including speckle tracking strain) that are linked to CRT response and a
      better outcome following CRT.
observational model: Cohort
time perspective: Prospective
measure: Changes in left ventricular end-systolic volume measured by echocardiography
time frame: 9 months after implantation
measure: Death rate
time frame: 2, 4, 6, 8 and 10 years after implantation
measure: re-hospitalisation rate
time frame: 2, 4, 6, 8 and 10 years after implantation
measure: Changes in left ventricular ejection fraction measured by echocardiography
time frame: 9 months after implantation
measure: Changes in left ventricular end-diastolic volume measured by echocardiography
time frame: 9 months after implantation
measure: Changes in left ventricular longitudinal strain measured by echocardiography
time frame: 9 months after implantation
arm group label: Patients with heart failure and CRT
description: Heart failure with left ventricular ejection fraction less than 35 % treated with CRT
intervention type: Other
intervention name: Echocardiography
arm group label: Patients with heart failure and CRT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvestre Maréchaux, MD, PhD
role: Principal Investigator
affiliation: Hospital of Lille Catholic University (GHICL)
last name: Amélie Lansiaux, MD, PhD
phone: 00 33 3 20 52 69
email: lansiaux.amelie@ghicl.net
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure