xml: <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/NCT06038123</url>
    </required_header>
    <id_info>
      <org_study_id>MDT23009</org_study_id>
      <nct_id>NCT06038123</nct_id>
    </id_info>
    <brief_title>China 3T MRI Study</brief_title>
    <official_title>China CIED 3.0T MRI Performance 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 purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan&#xD;
        CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. ll subjects will&#xD;
        have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will&#xD;
        occur at the MRI visit. The MRI scan region will be determined by investigator according to&#xD;
        the subject's clinical condition.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 7, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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 occurrence of an MRI-related event for CIED</measure>
      <time_frame>The event will be collected within 30 days after MRI visit.</time_frame>
      <description>The occurrence of any of the following within 30 days after the 3.0T MRI visit will be considered an MRI-related event for CIED:&#xD;
  Medical advisor-assessed MRI-related complication within 30 days post-MRI&#xD;
  Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI&#xD;
  Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock) as assessed by a medical advisor.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The changes in atrial and ventricular pacing capture thresholds of APCT from pre-MRI to 1-month post-MRI scan.</measure>
      <time_frame>The evaluation will be compared from pre-MRI to 1-month post-MRI scan</time_frame>
      <description>PCTs to be evaluated include:&#xD;
  Atrial pacing capture threshold (if applicable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in atrial and ventricular pacing capture thresholds of VPCT from pre-MRI to 1-month post-MRI scan.</measure>
      <time_frame>The evaluation will be compared from pre-MRI to 1-month post-MRI scan</time_frame>
      <description>PCTs to be evaluated include:&#xD;
  Ventricular pacing capture threshold (both right and left ventricular lead if applicable)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Bradycardia</condition>
    <condition>Tachycardia</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Signal arm, To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>China market released 3.0T Magnetic resonance (MR) conditional CIED systems</intervention_name>
      <description>To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body)</description>
      <arm_group_label>Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects who were implanted an SureScan system CIED over 6 weeks at the time of&#xD;
               signing ICF.&#xD;
  &#xD;
            -  Subjects who are able and willing to undergo elective MRI scanning without sedation.&#xD;
  &#xD;
            -  Subjects who were implanted an SureScan system CIED in the pectoral region.&#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 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 CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up.&#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&#xD;
               SureScan 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;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Peter Tang, Master</last_name>
      <phone>+86 15921265787</phone>
      <email>peter.tang@medtronic.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Tachycardia</mesh_term>
      <mesh_term>Bradycardia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038123
  org study id: MDT23009
  nct id: NCT06038123
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan
        CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. ll subjects will
        have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will
        occur at the MRI visit. The MRI scan region will be determined by investigator according to
        the subject's clinical condition.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The occurrence of an MRI-related event for CIED
  time frame: The event will be collected within 30 days after MRI visit.
  description: The occurrence of any of the following within 30 days after the 3.0T MRI visit will be considered an MRI-related event for CIED:
  Medical advisor-assessed MRI-related complication within 30 days post-MRI
  Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI
  Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock) as assessed by a medical advisor.
  measure: The changes in atrial and ventricular pacing capture thresholds of APCT from pre-MRI to 1-month post-MRI scan.
  time frame: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
  description: PCTs to be evaluated include:
  Atrial pacing capture threshold (if applicable)
  measure: The changes in atrial and ventricular pacing capture thresholds of VPCT from pre-MRI to 1-month post-MRI scan.
  time frame: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
  description: PCTs to be evaluated include:
  Ventricular pacing capture threshold (both right and left ventricular lead if applicable)
  arm group label: Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans
  arm group type: Experimental
  description: Signal arm, To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment
  intervention type: Device
  intervention name: China market released 3.0T Magnetic resonance (MR) conditional CIED systems
  description: To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body)
  arm group label: Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Peter Tang, Master
  phone: +86 15921265787
  email: peter.tang@medtronic.com
  responsible party type: Sponsor
  mesh term: Tachycardia
  mesh term: Bradycardia