<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/NCT03811691</url>
  </required_header>
  <id_info>
    <org_study_id>IBSY06 - CAPRI</org_study_id>
    <nct_id>NCT03811691</nct_id>
  </id_info>
  <brief_title>Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment</brief_title>
  <acronym>CAPRI</acronym>
  <official_title>Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MicroPort CRM</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MicroPort CRM</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>
      The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO&#xD;
      pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI&#xD;
      solutions guideline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR&#xD;
      conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s).&#xD;
      Conditions to undergo an MRI scan are provided in the MRI solutions guideline.&#xD;
&#xD;
      The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when&#xD;
      used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.&#xD;
&#xD;
      The study secondary main objectives are aiming to assess the performance of the MR&#xD;
      conditional pacing system in the right atrium and ventricle at 1 month following the MRI&#xD;
      scan:&#xD;
&#xD;
        -  Stability of the Pacing Capture Threshold&#xD;
&#xD;
        -  Stability of the lead sensed amplitude&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 18, 2019</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system</measure>
    <time_frame>1 month post MRI</time_frame>
    <description>An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication.&#xD;
The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan</measure>
    <time_frame>1 month post MRI</time_frame>
    <description>Subject's ventricular pacing capture threshold will be measured in Volt (V) at 0.5ms at baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan</measure>
    <time_frame>1 month post MRI</time_frame>
    <description>Subject's atrial pacing capture threshold will be measured in Volt (V) at 0.5ms at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan</measure>
    <time_frame>1 month post MRI</time_frame>
    <description>Subject's ventricular minimum sensed amplitude will be measured in mV at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as 50% or less decrease between the two visits. If subject's ventricular minimum sensed amplitude is less or equal to 4mV at time of baseline, then this subject will not count for this endpoint. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan</measure>
    <time_frame>1 month post MRI</time_frame>
    <description>Subject's atrial minimum sensed amplitude will be measured in mV at baseline. A success is defined as 50% or less decrease between the two visits. If subject's atrial minimum sensed amplitude is less or equal to 1mV at time of Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit, then this subject will not count for this endpoint.The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Bradycardia</condition>
  <arm_group>
    <arm_group_label>1.5 Tesla MRI Scan</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo 1.5T MRI exam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 Tesla MRI Scan</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo 3T MRI exam</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI exam</intervention_name>
    <description>Pacing system safety and stability under MRI scan environment</description>
    <arm_group_label>1.5 Tesla MRI Scan</arm_group_label>
    <arm_group_label>3 Tesla MRI Scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects who meet all the following criteria at the time of inclusion visit may be&#xD;
        included:&#xD;
&#xD;
          -  Already implanted in the left or right pectoral region for at least 6 weeks with:&#xD;
&#xD;
               -  ENO, TEO or OTO single chamber rate response (SR) pacemaker with a VEGA pacing&#xD;
                  lead, or&#xD;
&#xD;
               -  ENO, TEO or OTO dual chamber rate response (DR) pacemaker with two VEGA pacing&#xD;
                  leads.&#xD;
&#xD;
          -  Implanted pacing system must fulfill the following parameters:&#xD;
&#xD;
               -  Battery impedance is &lt; 5 Kilo Ohm (kΩ)&#xD;
&#xD;
               -  Pacing capture threshold value is ≤ 2 Volts (V) at 0.35 millisecond (ms)&#xD;
&#xD;
               -  Lead impedance value between 200Ω and 3000Ω&#xD;
&#xD;
               -  No diaphragmatic or pectoral stimulation at 5V/1ms&#xD;
&#xD;
               -  P-wave minimum sensed amplitude ≥ 1mV for patients with sinus rhythm&#xD;
&#xD;
               -  R-wave minimum sensed amplitude ≥ 4mV for patients with spontaneous conduction&#xD;
                  rhythm&#xD;
&#xD;
          -  Must agree to undergo a non clinically-indicated MRI scan without intravenous&#xD;
             injection and without sedation;&#xD;
&#xD;
          -  Have reviewed, signed and dated informed consent.&#xD;
&#xD;
        Subjects who meet any of the following criteria are not eligible to be included in the&#xD;
        study:&#xD;
&#xD;
          -  Included in another clinical study that could confound the results of this study such&#xD;
             as studies involving intra-cardiac device;&#xD;
&#xD;
          -  Have other active or abandoned cardiac implants already implanted;&#xD;
&#xD;
          -  Have other active or passive non MR conditional devices implanted such as metallic&#xD;
             foreign body;&#xD;
&#xD;
          -  Have a history of brain aneurysm with ferromagnetic clipping;&#xD;
&#xD;
          -  Have a planned cardiac surgery within the 3 months of inclusion;&#xD;
&#xD;
          -  Have a medical MRI examination prescription planned within the 3 months of inclusion;&#xD;
&#xD;
          -  Age less than 18 years old or under guardianship or kept in detention;&#xD;
&#xD;
          -  Known pregnancy, women breastfeeding or in childbearing age without an adequate&#xD;
             contraceptive method ;&#xD;
&#xD;
          -  Be unavailable for the scheduled follow-up associated with this clinical study or&#xD;
             refusal to cooperate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anne RousseauPlasse</last_name>
    <phone>01 46 01 30 82</phone>
    <phone_ext>+33</phone_ext>
    <email>Anne.RousseauPlasse@crm.microport.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hanan Fawaz</last_name>
    <phone>01 46 01 89 01</phone>
    <phone_ext>+33</phone_ext>
    <email>hanan.fawaz@crm.microport.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>MicroPort CRM</name>
      <address>
        <city>Clamart</city>
        <state>Haut De Seine</state>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne RousseauPlasse</last_name>
      <phone>01 46 01 30 82</phone>
      <phone_ext>+33</phone_ext>
      <email>Anne.RousseauPlasse@crm.microport.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</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>Bradycardia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 20, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03811691
org study id: IBSY06 - CAPRI
nct id: NCT03811691
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO
      pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI
      solutions guideline.
The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR
      conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s).
      Conditions to undergo an MRI scan are provided in the MRI solutions guideline.

      The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when
      used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.

      The study secondary main objectives are aiming to assess the performance of the MR
      conditional pacing system in the right atrium and ventricle at 1 month following the MRI
      scan:

        -  Stability of the Pacing Capture Threshold

        -  Stability of the lead sensed amplitude
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.
primary purpose: Other
masking: None (Open Label)
measure: Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
time frame: 1 month post MRI
description: An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication.
The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
measure: Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan
time frame: 1 month post MRI
description: Subject's ventricular pacing capture threshold will be measured in Volt (V) at 0.5ms at baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
measure: Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan
time frame: 1 month post MRI
description: Subject's atrial pacing capture threshold will be measured in Volt (V) at 0.5ms at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
measure: Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan
time frame: 1 month post MRI
description: Subject's ventricular minimum sensed amplitude will be measured in mV at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as 50% or less decrease between the two visits. If subject's ventricular minimum sensed amplitude is less or equal to 4mV at time of baseline, then this subject will not count for this endpoint. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
measure: Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan
time frame: 1 month post MRI
description: Subject's atrial minimum sensed amplitude will be measured in mV at baseline. A success is defined as 50% or less decrease between the two visits. If subject's atrial minimum sensed amplitude is less or equal to 1mV at time of Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit, then this subject will not count for this endpoint.The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
arm group label: 1.5 Tesla MRI Scan
arm group type: Other
description: Subjects will undergo 1.5T MRI exam
arm group label: 3 Tesla MRI Scan
arm group type: Other
description: Subjects will undergo 3T MRI exam
intervention type: Diagnostic Test
intervention name: MRI exam
description: Pacing system safety and stability under MRI scan environment
arm group label: 1.5 Tesla MRI Scan
arm group label: 3 Tesla MRI Scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne RousseauPlasse
phone: 01 46 01 30 82
phone ext: +33
email: Anne.RousseauPlasse@crm.microport.com
last name: Hanan Fawaz
phone: 01 46 01 89 01
phone ext: +33
email: hanan.fawaz@crm.microport.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Bradycardia
sharing ipd: No
submitted: December 20, 2022