<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/NCT03779802</url>
  </required_header>
  <id_info>
    <org_study_id>2018/10</org_study_id>
    <nct_id>NCT03779802</nct_id>
  </id_info>
  <brief_title>Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients</brief_title>
  <acronym>3 STIM</acronym>
  <official_title>Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.</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.&#xD;
&#xD;
      Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of&#xD;
      stimulation can influence the acute hemodynamical consequences of CRT but also its&#xD;
      medium-term and long-term clinical and echocardiographic effects.&#xD;
&#xD;
      The aim of the present prospective study is to investigate whether the different stimulation&#xD;
      modes lead to different acute hemodynamic response, by evaluating the highest systolic&#xD;
      pressure using the Finapress ® method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a non-randomized, prospective, interventional, multicentric study.&#xD;
&#xD;
      Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months&#xD;
      are eligible for the study.&#xD;
&#xD;
      Recruited patients will be submitted to a non-invasive evaluation of different pacing modes.&#xD;
      This will be performed using the Finapress NOVA device, which records blood pressure with a&#xD;
      digital cuff. The peak of blood pressure will correspond to the optimal device settings&#xD;
&#xD;
      Three modes of stimulation of ABBOTT CRT devices will be compared:&#xD;
&#xD;
        -  Classical bi-ventricular pacing mode at nominal value and with AV delay optimization&#xD;
&#xD;
        -  SyncAV mode at nominal value or with left ventricular preexcitation optimization&#xD;
&#xD;
        -  Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute&#xD;
           evaluation study without scheduled follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    With the current health situation, we do not anticipate a significant resumption of recruitment&#xD;
    for several months.&#xD;
  </why_stopped>
  <start_date type="Actual">April 23, 2019</start_date>
  <completion_date type="Actual">April 18, 2020</completion_date>
  <primary_completion_date type="Actual">April 18, 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>day 0</time_frame>
    <description>Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other hemodynamical response</measure>
    <time_frame>day 0</time_frame>
    <description>Cardiac output</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other hemodynamical response</measure>
    <time_frame>day 0</time_frame>
    <description>Systolic ejection volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other hemodynamical response</measure>
    <time_frame>day 0</time_frame>
    <description>dP/dT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Resynchronization Therapy</condition>
  <arm_group>
    <arm_group_label>CRT device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Device programming of ABBOTT CRT pacemaker or defibrillator</intervention_name>
    <description>Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.</description>
    <arm_group_label>CRT device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18&#xD;
&#xD;
          -  Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion&#xD;
&#xD;
          -  MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system&#xD;
&#xD;
          -  Patient who had signed an informed consent and is willing to comply with study&#xD;
             requirements&#xD;
&#xD;
          -  De novo implantation&#xD;
&#xD;
          -  Patient covered by national healthcare insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia&#xD;
&#xD;
          -  Pacing indication for 2nd or 3rd degree AV block&#xD;
&#xD;
          -  Upgrading from non-CRT system&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Adult 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>
  <overall_official>
    <last_name>Ghassan MD MOUBARAK</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMC Ambroise Paré</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gehm Site D'Eaubonne</name>
      <address>
        <city>Eaubonne</city>
        <state>Val-d'Oise</state>
        <zip>95600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cmc Ambroise Pare</name>
      <address>
        <city>Neuilly sur seine</city>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac Resynchronization Therapy</keyword>
  <keyword>Atrioventricular delay optimization</keyword>
  <keyword>Multipoint pacing</keyword>
  <keyword>Negative atrioventricular hysteresis</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/NCT03779802
org study id: 2018/10
nct id: NCT03779802
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.

      Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of
      stimulation can influence the acute hemodynamical consequences of CRT but also its
      medium-term and long-term clinical and echocardiographic effects.

      The aim of the present prospective study is to investigate whether the different stimulation
      modes lead to different acute hemodynamic response, by evaluating the highest systolic
      pressure using the Finapress ® method.
This study is a non-randomized, prospective, interventional, multicentric study.

      Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months
      are eligible for the study.

      Recruited patients will be submitted to a non-invasive evaluation of different pacing modes.
      This will be performed 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

      Three modes of stimulation of ABBOTT CRT devices will be compared:

        -  Classical bi-ventricular pacing mode at nominal value and with AV delay optimization

        -  SyncAV mode at nominal value or with left ventricular preexcitation optimization

        -  Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute
           evaluation study without scheduled follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemodynamic response
time frame: day 0
description: Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation
measure: Other hemodynamical response
time frame: day 0
description: Cardiac output
measure: Other hemodynamical response
time frame: day 0
description: Systolic ejection volume
measure: Other hemodynamical response
time frame: day 0
description: dP/dT
arm group label: CRT device
arm group type: Experimental
description: Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes
intervention type: Other
intervention name: Device programming of ABBOTT CRT pacemaker or defibrillator
description: Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.
arm group label: CRT device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ghassan MD MOUBARAK
role: Principal Investigator
affiliation: CMC Ambroise Paré
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No