<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/NCT03261063</url>
  </required_header>
  <id_info>
    <org_study_id>China Evera</org_study_id>
    <nct_id>NCT03261063</nct_id>
  </id_info>
  <brief_title>China Evera MRI® Study</brief_title>
  <official_title>China Evera MRI® Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</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 study is a prospective, single arm, non-blinded, multi-site study conducted in mainland&#xD;
      China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in&#xD;
      the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up&#xD;
      to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur&#xD;
      anywhere on the body). Long-term device effects, such as long-term lead integrity, will not&#xD;
      be assessed in the China Evera MRI® study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">September 26, 2018</completion_date>
  <primary_completion_date type="Actual">September 26, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of successful MRI scans</measure>
    <time_frame>1 Month Follow up visit after MRI Scan Visit</time_frame>
    <description>To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effectiveness of the Evera MRI device post-MRI.</measure>
    <time_frame>Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.</time_frame>
    <description>The effectiveness of the Evera MRI device will be measured by the following parameters&#xD;
Atrial pacing capture threshold (only for dual chamber devices)&#xD;
Atrial sensing amplitude (only for dual chamber devices)&#xD;
Ventricular pacing capture threshold&#xD;
Ventricular sensing amplitude These parameters will be measured pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <arm_group>
    <arm_group_label>Evera Implanted Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Evera MRI ICD System</intervention_name>
    <description>Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements</description>
    <arm_group_label>Evera Implanted Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are indicated for implantation of an ICD at the time of study enrollment.&#xD;
&#xD;
          -  Subjects who are able to undergo a pectoral implant.&#xD;
&#xD;
          -  Subjects who are able and willing to undergo elective MRI scanning without sedation ,&#xD;
             .&#xD;
&#xD;
          -  Subjects who are geographically stable and available for follow-up at the study site&#xD;
             for the length of the study.&#xD;
&#xD;
          -  Subjects who are at least 18 years of age (or older, if required by local law).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of significant tricuspid valvular disease that precludes the&#xD;
             ability to place the RV lead. .&#xD;
&#xD;
          -  Subjects who may be contraindicated to the dexamethasone sodium phosphate and/or&#xD;
             dexamethasone acetate.&#xD;
&#xD;
          -  Subjects who require a legally authorized representative to obtain informed consent.&#xD;
&#xD;
          -  Subjects with abandoned or capped leads.&#xD;
&#xD;
          -  Subjects who require an indicated MRI scan, other than those specifically described in&#xD;
             the China Evera MRI® study, before the one-month post-MRI follow-up (approximately 4&#xD;
             months post-implant).&#xD;
&#xD;
          -  Subjects with a non-MRI compatible device (such as neurostimulators) or material&#xD;
             implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators,&#xD;
             metals or alloys).&#xD;
&#xD;
          -  Subjects with medical conditions that preclude the testing required by the CIP or&#xD;
             limit study participation.&#xD;
&#xD;
          -  Subjects who are enrolled or intend to participate in another clinical trial (of an&#xD;
             investigational drug or device, new indication for an approved drug or device, or&#xD;
             requirement of additional testing beyond standard clinical practice) during the China&#xD;
             Evera MRI® study. Co-enrollment in concurrent trials is only allowed when documented&#xD;
             pre-approval is obtained from the Medtronic study manager.&#xD;
&#xD;
          -  Female patient who is pregnant, or of childbearing potential and not on a reliable&#xD;
             form of birth control. Women of childbearing potential are required to have a negative&#xD;
             pregnancy test within seven (7) days prior to device implant&#xD;
&#xD;
          -  Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).&#xD;
&#xD;
          -  Subjects who are diagnosed with terminal disease with life expectancy less than 4&#xD;
             months.&#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>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hua Xi Hospital (West China Hospital)</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>October 12, 2018</last_update_submitted>
  <last_update_submitted_qc>October 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</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>Arrhythmias, Cardiac</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/NCT03261063
org study id: China Evera
nct id: NCT03261063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland
      China.
The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in
      the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up
      to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur
      anywhere on the body). Long-term device effects, such as long-term lead integrity, will not
      be assessed in the China Evera MRI® study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion of successful MRI scans
time frame: 1 Month Follow up visit after MRI Scan Visit
description: To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device.
measure: The effectiveness of the Evera MRI device post-MRI.
time frame: Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.
description: The effectiveness of the Evera MRI device will be measured by the following parameters
Atrial pacing capture threshold (only for dual chamber devices)
Atrial sensing amplitude (only for dual chamber devices)
Ventricular pacing capture threshold
Ventricular sensing amplitude These parameters will be measured pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.
arm group label: Evera Implanted Group
arm group type: Experimental
intervention type: Device
intervention name: Evera MRI ICD System
description: Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements
arm group label: Evera Implanted Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac