<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/NCT03750058</url>
  </required_header>
  <id_info>
    <org_study_id>2017/170/HP</org_study_id>
    <nct_id>NCT03750058</nct_id>
  </id_info>
  <brief_title>Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy</brief_title>
  <acronym>AXONE-Acute</acronym>
  <official_title>AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MicroPort CRM</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Rouen</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>
      Pilot study to evaluate the performance of a lead below 2 French with specific distal shape&#xD;
      to deliver efficient LV pacing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2018</start_date>
  <completion_date type="Actual">December 13, 2018</completion_date>
  <primary_completion_date type="Actual">December 13, 2018</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LV Multizone pacing success rate</measure>
    <time_frame>20 min</time_frame>
    <description>Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LV pacing success rate</measure>
    <time_frame>20 min</time_frame>
    <description>Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant testing Procedure-related Adverse Events procedure.</measure>
    <time_frame>1 month post testing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical performance of device (1)</measure>
    <time_frame>20 min</time_frame>
    <description>Electrical performance focusing on LV pacing threshold (Volts)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical performance of device (2)</measure>
    <time_frame>20 min</time_frame>
    <description>Electrical performance focusing on LV pacing impedance (Ohm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lead Implant Efficiency</measure>
    <time_frame>20 min</time_frame>
    <description>procedure time for successful placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lead Implant Efficiency</measure>
    <time_frame>20 min</time_frame>
    <description>Radiation dose during implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of implanter</measure>
    <time_frame>20 min</time_frame>
    <description>handling assessment of implanter using satisfaction scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiac Resynchronisation Therapy</condition>
  <arm_group>
    <arm_group_label>Implant test procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implant test procedure</intervention_name>
    <description>Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy</description>
    <arm_group_label>Implant test procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patient aged ≥18 years old.&#xD;
&#xD;
          -  Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines&#xD;
             .&#xD;
&#xD;
          -  Primary implant of a CRT device (including upgrade from a single or dual-chamber&#xD;
             pacemaker or ICD).&#xD;
&#xD;
          -  Signed and dated informed consent.&#xD;
&#xD;
          -  Patient affiliated with, or beneficiary of a social security category.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Class IV of NYHA (ambulatory or not).&#xD;
&#xD;
          -  Allergy to contrast media used for imaging during cardiac catheterization.&#xD;
&#xD;
          -  Severe Renal Failure (clearance of creatinine &lt; 30ml/mn/m²).&#xD;
&#xD;
          -  Previous failure catheterization of the coronary sinus, or previous failure of left&#xD;
             ventricular lead implantation.&#xD;
&#xD;
          -  Already included in another clinical study involving intra-cardiac active implantable&#xD;
             device, or participation to any other clinical trial in the last 2 weeks.&#xD;
&#xD;
          -  Person deprived of liberty by administrative or judicial decision or placed under&#xD;
             judicial protection (guardianship or supervision).&#xD;
&#xD;
          -  Known pregnancy, breastfeeding women or in childbearing age without an adequate&#xD;
             contraceptive method (failure rate &lt; 1%).&#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>Frédéric ANSELME, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bordeaux University Hospital</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lille University Hospital</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quadripolar LV leads</keyword>
  <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/NCT03750058
org study id: 2017/170/HP
nct id: NCT03750058
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape
      to deliver efficient LV pacing
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: LV Multizone pacing success rate
time frame: 20 min
description: Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms
measure: LV pacing success rate
time frame: 20 min
description: Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms
measure: Implant testing Procedure-related Adverse Events procedure.
time frame: 1 month post testing
measure: Electrical performance of device (1)
time frame: 20 min
description: Electrical performance focusing on LV pacing threshold (Volts)
measure: Electrical performance of device (2)
time frame: 20 min
description: Electrical performance focusing on LV pacing impedance (Ohm)
measure: Lead Implant Efficiency
time frame: 20 min
description: procedure time for successful placement
measure: Lead Implant Efficiency
time frame: 20 min
description: Radiation dose during implant
measure: Satisfaction of implanter
time frame: 20 min
description: handling assessment of implanter using satisfaction scale
arm group label: Implant test procedure
arm group type: Experimental
description: Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
intervention type: Device
intervention name: Implant test procedure
description: Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
arm group label: Implant test procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frédéric ANSELME, Pr
role: Principal Investigator
affiliation: Rouen University Hospital
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No