<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/NCT03789487</url>
  </required_header>
  <id_info>
    <org_study_id>2018/09</org_study_id>
    <nct_id>NCT03789487</nct_id>
  </id_info>
  <brief_title>Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients</brief_title>
  <acronym>OPTIREG</acronym>
  <official_title>Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CMC Ambroise Paré</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CMC Ambroise Paré</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>
      Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with&#xD;
      systolic heart failure and bundle branch block, improving functional capacity, quality of&#xD;
      life and reducing morbi-mortality. However, one-third of patients are non-responders. Among&#xD;
      factors associated with non-response, suboptimal electrical settings of the device, i.e.&#xD;
      inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.&#xD;
&#xD;
      The aim of the study is to investigate whether the optimization of CRT settings (pacing&#xD;
      vector and AV delay) results in improved clinical and echocardiographic outcomes in a&#xD;
      non-responder CRT population after 6 months of therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is non-randomized, prospective, interventional, multicentric study. Patients who&#xD;
      have been implanted with a CRT device between 6 and 18 months prior to inclusion and are&#xD;
      considered non-responders are eligible for this study. CRT non-response can be clinical (lack&#xD;
      of functional improvement or hospitalization for heart failure) and/or echocardiographic&#xD;
      (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria,&#xD;
      permanent atrial fibrillation is of note.&#xD;
&#xD;
      Recruited patients will be submitted to an optimization procedure of their CRT device&#xD;
      settings. This will be performed with a non-invasive method using the Finapress NOVA device,&#xD;
      which records blood pressure with a digital cuff. The peak of blood pressure will correspond&#xD;
      to the optimal device settings. The first step will be to chose the best pacing vector. The&#xD;
      second step will be to chose the best AV delay. The best setting, i.e. associated with the&#xD;
      highest blood pressure, will be programmed at the end of the optimization protocol.&#xD;
&#xD;
      The patients will be followed at 6 months with clinical evaluation and echocardiography to&#xD;
      assess the conversion rate of non-responders to responders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    the end of inclusion period&#xD;
  </why_stopped>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Actual">September 14, 2020</completion_date>
  <primary_completion_date type="Actual">August 21, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemodynamic response</measure>
    <time_frame>During the optimization session</time_frame>
    <description>Highest Systolic Blood Pressure (SBP) obtained by stimulation vector</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>echocardiographic response</measure>
    <time_frame>at 6 months of follow-up</time_frame>
    <description>Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response</measure>
    <time_frame>at 6 months of follow up</time_frame>
    <description>Hospitalization for heart failure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Resynchronization Therapy</condition>
  <arm_group>
    <arm_group_label>Non-responders to CRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-responders to CRT who will undergo an electrical optimization of the settings of their device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device programming of CRT pacemaker or defibrillator</intervention_name>
    <description>Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device</description>
    <arm_group_label>Non-responders to CRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18&#xD;
&#xD;
          -  Patient implanted with a CRT (CRT-P or CRT-D) more than 6 months but less than 18&#xD;
             months before inclusion&#xD;
&#xD;
          -  Non-responder patients:&#xD;
&#xD;
        Clinical criteria (Packer classification):&#xD;
&#xD;
        Lack of improvement of NYHA functional class And/or hospitalization for heart failure&#xD;
&#xD;
        Echocardiographic criteria:&#xD;
&#xD;
        Lack of improvement of LVEF &gt; 5points And/or reduction of LVESV &lt; 15%&#xD;
&#xD;
          -  Patient who had signed an informed consent and is willing to comply with study&#xD;
             requirements&#xD;
&#xD;
          -  Patient covered by French national healthcare insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia&#xD;
&#xD;
          -  Scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6&#xD;
             coming months&#xD;
&#xD;
          -  Life-expectancy of less than 6 months&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Adults under legal protection&#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>CMC Ambroise Paré</name>
      <address>
        <city>Neuilly-sur-Seine</city>
        <state>Ile De France</state>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHEM Eaubonne</name>
      <address>
        <city>Montmorency</city>
        <zip>95160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Resynchronization Therapy</keyword>
  <keyword>Non-responders</keyword>
  <keyword>Pacing vector optimization</keyword>
  <keyword>Atrioventricular delay optimization</keyword>
  <keyword>Non invasive hemodynamic optimization</keyword>
  <keyword>Heart Failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03789487
org study id: 2018/09
nct id: NCT03789487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with
      systolic heart failure and bundle branch block, improving functional capacity, quality of
      life and reducing morbi-mortality. However, one-third of patients are non-responders. Among
      factors associated with non-response, suboptimal electrical settings of the device, i.e.
      inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.

      The aim of the study is to investigate whether the optimization of CRT settings (pacing
      vector and AV delay) results in improved clinical and echocardiographic outcomes in a
      non-responder CRT population after 6 months of therapy.
This study is non-randomized, prospective, interventional, multicentric study. Patients who
      have been implanted with a CRT device between 6 and 18 months prior to inclusion and are
      considered non-responders are eligible for this study. CRT non-response can be clinical (lack
      of functional improvement or hospitalization for heart failure) and/or echocardiographic
      (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria,
      permanent atrial fibrillation is of note.

      Recruited patients will be submitted to an optimization procedure of their CRT device
      settings. This will be performed with a non-invasive method using the Finapress NOVA device,
      which records blood pressure with a digital cuff. The peak of blood pressure will correspond
      to the optimal device settings. The first step will be to chose the best pacing vector. The
      second step will be to chose the best AV delay. The best setting, i.e. associated with the
      highest blood pressure, will be programmed at the end of the optimization protocol.

      The patients will be followed at 6 months with clinical evaluation and echocardiography to
      assess the conversion rate of non-responders to responders.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemodynamic response
time frame: During the optimization session
description: Highest Systolic Blood Pressure (SBP) obtained by stimulation vector
measure: echocardiographic response
time frame: at 6 months of follow-up
description: Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)
measure: Clinical response
time frame: at 6 months of follow up
description: Hospitalization for heart failure
arm group label: Non-responders to CRT
arm group type: Experimental
description: Non-responders to CRT who will undergo an electrical optimization of the settings of their device
intervention type: Device
intervention name: Device programming of CRT pacemaker or defibrillator
description: Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device
arm group label: Non-responders to CRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No