<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/NCT03012568</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10137</org_study_id>
    <nct_id>NCT03012568</nct_id>
  </id_info>
  <brief_title>Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems</brief_title>
  <acronym>ASSUREMRI</acronym>
  <official_title>ASSURE MRI Study - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical investigational plan (CIP) for the &quot;Clinical Study to Confirm MRI Safety&#xD;
      and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)&quot;. This study&#xD;
      intends to enroll patients who meet standard bradycardia or tachycardia indications and have&#xD;
      already been implanted with one of the SJM device/lead combinations listed in this protocol.&#xD;
      The objective of this study is to confirm the safety and effectiveness of each of the four&#xD;
      SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored&#xD;
      by St. Jude Medical.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center clinical study designed to confirm the safety and&#xD;
      effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber&#xD;
      Implantable Cardioverter-Defibrillators (ICD), and Cardiac Resynchronization Therapy&#xD;
      Defibrillators (CRT-D) with various leads in an MRI environment.&#xD;
&#xD;
      The study will enroll subjects across multiple geographies and sites. Sites in geographies&#xD;
      where MRI labelling is not yet approved may also be included after appropriate IRB/EC and&#xD;
      local regulatory approvals, as applicable, are obtained. A prospective, multi-center study&#xD;
      design is chosen for generalizability of study results.&#xD;
&#xD;
      The clinical study will be conducted in approximately 40 centers worldwide. Approximately 88&#xD;
      subjects total (with a minimum 22 subjects for each of the four device/lead combinations)&#xD;
      will be enrolled in this study.&#xD;
&#xD;
      Enrollment in the study is expected to take approximately 6-8 months. Subjects will be&#xD;
      followed for 1 month following the MRI scan. The total study duration of the study is&#xD;
      expected to be 10 months, depending on the rate of enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2016</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">January 26, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Endpoint: Freedom from MRI scan-related complications</measure>
    <time_frame>One month following the MRI scan.</time_frame>
  </primary_outcome>
  <enrollment type="Actual">119</enrollment>
  <condition>Bradycardia</condition>
  <condition>Tachycardia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SJM Implantable cardiac devices</intervention_name>
    <description>SJM implantable devices undergoing MRI scan</description>
    <other_name>ICD</other_name>
    <other_name>CRT-D</other_name>
    <other_name>Pacemakers</other_name>
    <other_name>CRT</other_name>
    <other_name>MRI</other_name>
    <other_name>Leads</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who meet standard bradycardia or tachycardia indications comprise the target&#xD;
        population for this study. The subject will be considered enrolled in the study after the&#xD;
        consent is signed and the MRI Settings have been programmed at the MRI visit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are implanted with one of the following SJM device/lead combinations evaluated in this&#xD;
             study for at least 60 days (can include patients with an eligible SJM lead for ≥ 60&#xD;
             days OR patients with a new eligible SJM pacemaker, Implantable&#xD;
             Cardioverter-Defibrillators (ICD), or Cardiac Resynchronization Therapy Defibrillators&#xD;
             (CRT-D) device and eligible SJM lead implanted for at least 60 days:&#xD;
&#xD;
               1. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with Tendril™&#xD;
                  STS Model 2088 lead&#xD;
&#xD;
               2. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with IsoFlex™&#xD;
                  Optim (Model 1944 or 1948) lead&#xD;
&#xD;
               3. Ellipse™ VR/DR or Fortify Assura VR/DR ICD with Tendril™ STS (Model 2088) or&#xD;
                  Tendril MRI™ and Durata™ or Optisure™ leads&#xD;
&#xD;
               4. Quadra Assura™ CRT-D with Tendril™ STS (Model 2088), Durata™ or Optisure™, and&#xD;
                  Quartet™ Quadripolar leads&#xD;
&#xD;
          -  Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device pectorally&#xD;
&#xD;
          -  Be willing to undergo an elective MRI scan without sedation. Note: Antianxiety agents&#xD;
             (e.g. minor tranquilizers, etc.) may be used as long as the subject can communicate&#xD;
             with site personnel during the MRI scan&#xD;
&#xD;
          -  Be able to provide informed consent for study participation (legal guardian is NOT&#xD;
             acceptable)&#xD;
&#xD;
          -  Be willing and able to comply with the prescribed follow-up tests and schedule of&#xD;
             evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have another existing active implanted medical device, e.g., neurostimulator, infusion&#xD;
             pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to&#xD;
             be completed.&#xD;
&#xD;
          -  Have other non-MRI compatible device or material implanted&#xD;
&#xD;
               -  NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be&#xD;
                  included as long as the labeling of these devices allow MRI scans conducted per&#xD;
                  this protocol&#xD;
&#xD;
               -  NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may&#xD;
                  be included as long as the labeling of these devices allow for MRI scans&#xD;
                  conducted per this protocol&#xD;
&#xD;
               -  NOTE: Non-removable dental implants may be included&#xD;
&#xD;
          -  Have a lead extender, adaptor, or capped/abandoned lead&#xD;
&#xD;
          -  Be unable to fit in MRI bore, i.e., subject will come into contact with the magnet&#xD;
             façade inside the MRI bore.&#xD;
&#xD;
          -  Are currently participating in a clinical investigation that includes an active&#xD;
             treatment arm&#xD;
&#xD;
          -  Are pregnant or planning to become pregnant during the duration of the study&#xD;
&#xD;
          -  Have a life expectancy of less than 3 months due to any condition&#xD;
&#xD;
          -  Meet exclusion criteria per local law (e.g. age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grant Kim</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Devices</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Care Partners - Wesley Hospital</name>
      <address>
        <city>Auchenflower</city>
        <state>Queensland</state>
        <zip>4066</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Care Western Australia</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CARE Banjara</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>India</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>August 2, 2019</last_update_submitted>
  <last_update_submitted_qc>August 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03012568
org study id: SJM-CIP-10137
nct id: NCT03012568
lead sponsor: 
has dmc: No
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety
      and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study
      intends to enroll patients who meet standard bradycardia or tachycardia indications and have
      already been implanted with one of the SJM device/lead combinations listed in this protocol.
      The objective of this study is to confirm the safety and effectiveness of each of the four
      SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored
      by St. Jude Medical.
This is a prospective, multi-center clinical study designed to confirm the safety and
      effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber
      Implantable Cardioverter-Defibrillators (ICD), and Cardiac Resynchronization Therapy
      Defibrillators (CRT-D) with various leads in an MRI environment.

      The study will enroll subjects across multiple geographies and sites. Sites in geographies
      where MRI labelling is not yet approved may also be included after appropriate IRB/EC and
      local regulatory approvals, as applicable, are obtained. A prospective, multi-center study
      design is chosen for generalizability of study results.

      The clinical study will be conducted in approximately 40 centers worldwide. Approximately 88
      subjects total (with a minimum 22 subjects for each of the four device/lead combinations)
      will be enrolled in this study.

      Enrollment in the study is expected to take approximately 6-8 months. Subjects will be
      followed for 1 month following the MRI scan. The total study duration of the study is
      expected to be 10 months, depending on the rate of enrollment.
observational model: Case-Only
time perspective: Prospective
measure: Safety Endpoint: Freedom from MRI scan-related complications
time frame: One month following the MRI scan.
intervention type: Device
intervention name: SJM Implantable cardiac devices
description: SJM implantable devices undergoing MRI scan
other name: ICD
other name: CRT-D
other name: Pacemakers
other name: CRT
other name: MRI
other name: Leads
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Grant Kim
role: Study Director
affiliation: Abbott Medical Devices
facility: 
facility: 
facility: 
country: Australia
country: India
responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Bradycardia
sharing ipd: Undecided