<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/NCT03828357</url>
  </required_header>
  <id_info>
    <org_study_id>CRD_930</org_study_id>
    <nct_id>NCT03828357</nct_id>
  </id_info>
  <brief_title>China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]</brief_title>
  <acronym>CN_MRI_ICD</acronym>
  <official_title>The Evaluation of ICD Defibrillation Systems in a 1.5T Magnetic Resonance Imaging Environment in China</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR&#xD;
      implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization&#xD;
      therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or&#xD;
      Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for&#xD;
      MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China.&#xD;
&#xD;
      Note: Protocol updated: Fortify Assura VR/DR ICD removed; Quadra Assura MP CRT-D and Quartet&#xD;
      leads added. The Detailed Description Section below was updated upon protocol amendment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endpoints, and contents of clinical study&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The objective of this clinical study is to evaluate the safety and effectiveness of the&#xD;
      Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac&#xD;
      resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation&#xD;
      leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI&#xD;
      environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems&#xD;
      in China.&#xD;
&#xD;
      There are four device combination groups in this clinical study as outlined below:&#xD;
&#xD;
        -  Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV).&#xD;
&#xD;
        -  Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril STS&#xD;
           lead in the right atrium (RA).&#xD;
&#xD;
        -  Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex lead&#xD;
           in the RA.&#xD;
&#xD;
        -  Group 4: Quadra Assura MP CRT-D with a Durata or Optisure lead in the RV, a Tendril STS&#xD;
           or Isoflex lead in the RA, and a Quartet lead in the left ventricle (LV).&#xD;
&#xD;
      Endpoints&#xD;
&#xD;
      Primary Endpoints&#xD;
&#xD;
        -  Safety: Freedom from MRI-scan related complications related to the ICD device and/or&#xD;
           leads from the time of the MRI scan to 1-month post-MRI scan testing.&#xD;
&#xD;
        -  Effectiveness: Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms&#xD;
           for RA and RV leads and ≤1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month&#xD;
           post-MRI scan testing.&#xD;
&#xD;
        -  Effectiveness: Proportion of leads with a sensing amplitude decrease of ≤ 50% from&#xD;
           pre-MRI scan testing to 1-month post-MRI scan.&#xD;
&#xD;
      Descriptive Endpoint(s)&#xD;
&#xD;
      Descriptive endpoints are reported using only summary statistics and no hypothesis tests will&#xD;
      be performed.&#xD;
&#xD;
      The following data will be collected:&#xD;
&#xD;
        1. Demographics: gender, age, ethnicity, race, cardiac disease history, arrhythmia history,&#xD;
           indication for ICD implant, history of smoking, etc.&#xD;
&#xD;
        2. Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1&#xD;
           Month Post Scan Visit&#xD;
&#xD;
        3. ADE, SADE, USADE&#xD;
&#xD;
        4. Mortality&#xD;
&#xD;
        5. Number of non-study MRI scans&#xD;
&#xD;
        6. Summarize number of subjects that returned to usual programming after the MRI scan and&#xD;
           number of subjects, if any, experiencing delays in reprogramming&#xD;
&#xD;
      This is a prospective, multi-center, single-arm study to evaluate the safety and&#xD;
      effectiveness of the Ellipse VR/DR ICDs, and the Quadra Assura MP CRT-D, with Durata or&#xD;
      Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet&#xD;
      quadripolar LV lead in a 1.5T MRI environment for MR-conditional labeling expansion in China.&#xD;
&#xD;
      This study will be conducted in at least 6 centers in China and at least 60 subjects who&#xD;
      provide consent for participation will be enrolled. Subjects will be considered enrolled&#xD;
      after providing consent. Subjects will be implanted with any one of the device/lead&#xD;
      combination groups outlined in Figure 1, depending on their clinical need as determined by&#xD;
      the Investigators. At least 15 subjects will be enrolled in each group.&#xD;
&#xD;
        -  Group 1 will have at least 15 enrolled subjects with the Ellipse VR single-chamber ICD&#xD;
           with a Durata lead in the RV.&#xD;
&#xD;
        -  Group 2 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD&#xD;
           with a Durata lead in the RV and a Tendril STS lead in the RA.&#xD;
&#xD;
        -  Group 3 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD&#xD;
           with a Optisure lead in the RV and a Isoflex lead in the RA.&#xD;
&#xD;
        -  Group 4 will have at least 15 enrolled subjects with a Quadra Assura MP CRT-D and an&#xD;
           Optisure or Durata lead in the RV, an Isoflex or Tendril STS lead in the RA, and a&#xD;
           Quartet lead in the LV.&#xD;
&#xD;
      The enrollment group and group 4 lead pairing will be at the discretion of the Investigator,&#xD;
      dependent on patient needs in conjunction with study needs to fulfill study goals.&#xD;
&#xD;
      At least forty-five (45) days after system implantation or after a system revision, subjects&#xD;
      will have a baseline visit followed by an MRI visit; subjects will undergo a study-related&#xD;
      MRI scan at 1.5T. Subjects will have a 1-month follow-up after the study MRI scan. The&#xD;
      minimum duration of each subject's participation is approximately 2.5 months from enrollment.&#xD;
      The expected duration of enrollment is approximately 14 months. The total duration of&#xD;
      clinical study is expected to be 16.5 months.&#xD;
&#xD;
      The study population includes male and female Chinese nationals that meet the eligibility&#xD;
      requirements and give consent for the study. Vulnerable subjects, such as minors or those&#xD;
      unable to provide consent are excluded from participating.&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
      Assessment for general eligibility criteria is based on medical records of the site and&#xD;
      interview with a candidate patient. If some of the clinical and laboratory tests are not&#xD;
      included in site standard tests, they must be done but after written informed consent is&#xD;
      obtained. Patients must meet ALL the inclusion criteria to be considered for the clinical&#xD;
      study. If ANY of the exclusion criteria are met, the patient is excluded from the clinical&#xD;
      study and cannot be enrolled.&#xD;
&#xD;
      To participate in this clinical study, the subject must meet all the following inclusion&#xD;
      criteria:&#xD;
&#xD;
        -  Have an approved indication for implantation of an ICD, or CRT-D&#xD;
&#xD;
        -  Be a Chinese national&#xD;
&#xD;
        -  Will be implanted with one of the following device/lead combinations evaluated in this&#xD;
           study:&#xD;
&#xD;
             -  Group 1: Ellipse VR single-chamber ICD with a Durata lead in the RV&#xD;
&#xD;
             -  Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril&#xD;
                STS lead in the RA&#xD;
&#xD;
             -  Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex&#xD;
                lead in the RA&#xD;
&#xD;
             -  Group 4: Quadra Assura MP CRT-D and an Optisure or Durata lead in the RV, an&#xD;
                Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV&#xD;
&#xD;
        -  Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant&#xD;
           NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the&#xD;
           patient can communicate with site personnel during the MRI scan&#xD;
&#xD;
        -  Be able to provide informed consent for study participation (legal guardian or legally&#xD;
           authorized representative is NOT acceptable)&#xD;
&#xD;
        -  Be willing and able to comply with the prescribed follow-up tests and procedures&#xD;
&#xD;
        -  Are not contraindicated for an MRI scan (per the MRI Screening Form)&#xD;
&#xD;
        -  Subjects who are at least 18 years of age (or older, required by local law)&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
      Subjects who meet any of the following exclusion criteria must be excluded from the clinical&#xD;
      investigation:&#xD;
&#xD;
        -  Have a competitor's MRI compatible endocardial lead implanted or capped&#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. The following examples may&#xD;
           be included as long as labelling of these devices allow MRI scans conducted per this&#xD;
           protocol:&#xD;
&#xD;
             -  MRI compatible knee replacements, hip replacements, stents, etc.&#xD;
&#xD;
             -  MRI compatible mechanical, prosthetic, and bio prosthetic heart valves&#xD;
&#xD;
             -  Non-removable dental implants&#xD;
&#xD;
        -  Have a lead extender, adaptor, or capped/abandoned lead&#xD;
&#xD;
        -  Enrolled or intend to participate in a clinical drug and/or device study&#xD;
           (investigational device, investigational drug, new indication for a device or drug or&#xD;
           additional testing beyond standard of care procedures), which could confound the results&#xD;
           of this study as determined by Abbott.&#xD;
&#xD;
        -  Pregnant or planning to become pregnant during the duration of the subject's&#xD;
           participation in the study&#xD;
&#xD;
        -  Have a life expectancy of less than 12 months due to any condition&#xD;
&#xD;
      Effectiveness evaluation method&#xD;
&#xD;
      There are two effectiveness endpoints to be evaluated in this study.&#xD;
&#xD;
        1. Description of the effectiveness endpoints&#xD;
&#xD;
             -  Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms for RA and&#xD;
                RV leads and ≤ 1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month post-MRI&#xD;
                scan testing.&#xD;
&#xD;
             -  Proportion leads with a sensing amplitude decrease of ≤ 50% from pre-MRI scan&#xD;
                testing to 1-month post-MRI scan.&#xD;
&#xD;
        2. Selection of method and time for evaluation, recording and analysis of the effectiveness&#xD;
           endpoints Since the objective is to evaluate the effect of MRI exposure for the ICD/&#xD;
           CRT-D device groups included in this study, the effectiveness parameters were selected&#xD;
           to compare abnormal changes in device performance from pre- to 1-month post- MRI scan.&#xD;
           The pre-MRI measurements are collected within the same day prior to the MRI scan. The&#xD;
           1-month post-MRI scan measurements are collected at 30 days post-MRI scan (within +14&#xD;
           days) to ensure any effect of the MRI exposure is captured.&#xD;
&#xD;
      The effectiveness parameters are recorded directly from the device. The device measurements&#xD;
      will be obtained using the Merlin programmer to interrogate the device during study visits.&#xD;
      The analysis of the effectiveness parameters will be conducted on all subjects with complete&#xD;
      data from pre- to 1-month post-MRI scan.&#xD;
&#xD;
      Safety evaluation method There is one safety primary endpoint to be evaluated in this study.&#xD;
&#xD;
        1. Description of the safety endpoint Freedom from MRI-scan related complications from the&#xD;
           time of the MRI scan to 1-month post-MRI scan testing.&#xD;
&#xD;
        2. Selection of method and time for evaluation, recording and analysis of the safety&#xD;
           endpoints Since the objective is to evaluate the effect of MRI exposure for the ICD/&#xD;
           CRT-D device groups included in this study, the safety parameters were selected to&#xD;
           include only MRI-scan related complications from the time of device programming for an&#xD;
           MRI scan to 1-month post-MRI scan. An independent physician CEC will adjudicate all&#xD;
           adverse device effects during this period to determine the relatedness to the MRI scan.&#xD;
&#xD;
      Safety surveillance within this study and the safety reporting, both performed by the&#xD;
      investigator, starts as soon as the subject completes the pre-MRI visit testing and the MRI&#xD;
      Settings have been programmed according to the protocol. The safety surveillance and the&#xD;
      safety reporting will continue until the last study visit has been performed, the subject is&#xD;
      deceased, the subject/investigator concludes his participation into the clinical study or the&#xD;
      subject withdrawal from the clinical study.&#xD;
&#xD;
      Monitoring plan&#xD;
&#xD;
      Sponsor and/or designee will monitor the clinical study over its duration according to the&#xD;
      CIP-specific monitoring plan which will include the planned extent of source data&#xD;
      verification.&#xD;
&#xD;
      Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the&#xD;
      following criteria are met:&#xD;
&#xD;
        -  The investigator understands and accepts the obligation to conduct the clinical study&#xD;
           according to the CIP and applicable regulations, and has signed the Clinical Trial&#xD;
           Agreement.&#xD;
&#xD;
        -  The Investigator and his/her staff should have sufficient time and facilities to conduct&#xD;
           the clinical study and should have access to an adequate number of appropriate subjects&#xD;
           to conduct the clinical study.&#xD;
&#xD;
        -  Source documentation (including original medical records) must be available to&#xD;
           substantiate proper informed consent procedures, adherence to CIP procedures, adequate&#xD;
           reporting and follow-up of adverse events, accuracy of data collected on case report&#xD;
           forms, and device information.&#xD;
&#xD;
        -  The Investigator/site will permit access to such records. A monitoring visit sign-in log&#xD;
           will be maintained at the site. The Investigator will agree to dedicate an adequate&#xD;
           amount of time to the monitoring process. The Investigator and/or research coordinator&#xD;
           will be available for monitoring visits. It is expected that the Investigator will&#xD;
           provide the monitor with a suitable working environment for review of clinical&#xD;
           study-related documents.&#xD;
&#xD;
      Statistical considerations&#xD;
&#xD;
      This study is an observational study to meet the requirements for device approval by the&#xD;
      National Medical Products Administration (NMPA, previously China FDA). There is no endpoint&#xD;
      hypotheses testing planned in this study. The endpoints, demographics, safety and device data&#xD;
      will be summarized using descriptive statistics as outlined in the Statistical Analysis Plan&#xD;
      (SAP).&#xD;
&#xD;
      Any major changes to the SAP will be documented in an amendment to the SAP. Less significant&#xD;
      changes to the planned analyses will be documented in the final report(s).&#xD;
&#xD;
      Data management&#xD;
&#xD;
      Study data will be handled according to China Device GCP (Order 25). The Leading PI and&#xD;
      his/her associated organization (leading Unit) will be responsible for compiling and&#xD;
      submitting all required reports to governmental agencies.&#xD;
&#xD;
      Before the submission, Leading PI and his/her associated organization (leading Unit) should&#xD;
      allow sponsor to have a copy of the above reports for reviewing, and providing comments for&#xD;
      Leading PI and his/her associated organization consideration.&#xD;
&#xD;
      Data will be analyzed by the Leading PI and his/her associated organization (leading Unit)&#xD;
      and/or its affiliates. The Leading PI and his/her associated organization (leading Unit)'s&#xD;
      also agree that data may be transferred to the Sponsor's locations worldwide and/or any other&#xD;
      worldwide regulatory authority in support of a market-approval application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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 outcomes: Freedom from Magnetic Resonance Imaging (MRI) scan related complications</measure>
    <time_frame>1 month</time_frame>
    <description>Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness outcomes: Proportion of leads with a capture threshold increase</measure>
    <time_frame>1 month</time_frame>
    <description>Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1-month post-MRI scan testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographics: Gender</measure>
    <time_frame>1 month</time_frame>
    <description>Gender</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics:Age</measure>
    <time_frame>1 month</time_frame>
    <description>Age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics: Ethnicity</measure>
    <time_frame>1 month</time_frame>
    <description>Ethnicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics: Race</measure>
    <time_frame>1 month</time_frame>
    <description>Race</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics: Medical History</measure>
    <time_frame>1 month</time_frame>
    <description>Cardiac disease history, arrhythmia history, indication for ICD implant, history of smoking, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device electrical measurements</measure>
    <time_frame>1 month</time_frame>
    <description>Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1 Month Post Scan Visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Device Events (ADE)</measure>
    <time_frame>1 month</time_frame>
    <description>Collect the number of ADEs for analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Adverse Device Events (SADE)</measure>
    <time_frame>1 month</time_frame>
    <description>Collect the number of SADEs for analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Unparticipated Serious Adverse Device Events (USADE)</measure>
    <time_frame>1 month</time_frame>
    <description>Collect the number of USADEs for analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Deaths</measure>
    <time_frame>1 month</time_frame>
    <description>Collect the number of ADEs for Mortality analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of non-study MRI scans</measure>
    <time_frame>1 month</time_frame>
    <description>Number of non-study MRI scans</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects that returned to usual programming</measure>
    <time_frame>1 month</time_frame>
    <description>The number of subjects that returned to usual programming after the MRI scan and number of subjects, if any, experiencing delays in reprogramming</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Tachycardia</condition>
  <arm_group>
    <arm_group_label>Ellipse VR with Durata</arm_group_label>
    <description>Ellipse VR single-chamber ICD with a Durata defibrillation lead</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ellipse DR with Durata &amp; Tendril STS</arm_group_label>
    <description>Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ellipse DR with Optisure and Isoflex</arm_group_label>
    <description>Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadra Assura MP CRT-D</arm_group_label>
    <description>Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study MRI scan</intervention_name>
    <description>At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.</description>
    <arm_group_label>Ellipse DR with Durata &amp; Tendril STS</arm_group_label>
    <arm_group_label>Ellipse DR with Optisure and Isoflex</arm_group_label>
    <arm_group_label>Ellipse VR with Durata</arm_group_label>
    <arm_group_label>Quadra Assura MP CRT-D</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes male and female Chinese nationals that meet the eligibility&#xD;
        requirements and give consent for the study. Vulnerable subjects, such as minors or those&#xD;
        unable to provide consent are excluded from participating.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To participate in this clinical study, the subject must meet all of the following inclusion&#xD;
        criteria:&#xD;
&#xD;
          -  Have an approved indication for implantation of a ICD&#xD;
&#xD;
          -  Be a Chinese national&#xD;
&#xD;
          -  Will be implanted with one of the following device/lead combinations evaluated in this&#xD;
             study:&#xD;
&#xD;
               -  Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle&#xD;
                  (RV)&#xD;
&#xD;
               -  Group 2: Fortify Assura single-chamber ICD, with an Optisure lead&#xD;
&#xD;
               -  Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril&#xD;
                  STS lead in the right atrium (RA)&#xD;
&#xD;
               -  Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in&#xD;
                  the RA&#xD;
&#xD;
          -  Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant&#xD;
             NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the&#xD;
             patient can communicate with site personnel during the MRI scan&#xD;
&#xD;
          -  Be able to provide informed consent for study participation (legal guardian or legally&#xD;
             authorized representative is NOT acceptable)&#xD;
&#xD;
          -  Be willing and able to comply with the prescribed follow-up tests and procedures&#xD;
&#xD;
          -  Are not contraindicated for an MRI scan (per the MRI Screening Form)&#xD;
&#xD;
          -  Subjects who are at least 18 years of age (or older, required by local law)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who meet any of the following exclusion criteria must be excluded from the&#xD;
        clinical investigation:&#xD;
&#xD;
          -  Have a competitor's MRI compatible endocardial lead implanted or capped&#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. The following examples may&#xD;
             be included as long as labelling of these devices allow MRI scans conducted per this&#xD;
             protocol:&#xD;
&#xD;
               -  MRI compatible knee replacements, hip replacements, stents, etc.&#xD;
&#xD;
               -  MRI compatible mechanical, prosthetic, and bio prosthetic heart valves&#xD;
&#xD;
               -  Non-removable dental implants&#xD;
&#xD;
          -  Have a lead extender, adaptor, or capped/abandoned lead&#xD;
&#xD;
          -  Enrolled or intend to participate in a clinical drug and/or device study&#xD;
             (investigational device, investigational drug, new indication for a device or drug or&#xD;
             additional testing beyond standard of care procedures), which could confound the&#xD;
             results of this study as determined by Abbott.&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during the duration of the subject's&#xD;
             participation in the study&#xD;
&#xD;
          -  Have a life expectancy of less than 12 months due to any condition&#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 First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 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>Tachycardia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>This has not yet been decided.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>March 10, 2022</submitted>
    <returned>June 13, 2022</returned>
    <submitted>March 1, 2023</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/NCT03828357
org study id: CRD_930
nct id: NCT03828357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR
      implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization
      therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or
      Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for
      MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China.

      Note: Protocol updated: Fortify Assura VR/DR ICD removed; Quadra Assura MP CRT-D and Quartet
      leads added. The Detailed Description Section below was updated upon protocol amendment.
Endpoints, and contents of clinical study

      Objectives:

      The objective of this clinical study is to evaluate the safety and effectiveness of the
      Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac
      resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation
      leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI
      environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems
      in China.

      There are four device combination groups in this clinical study as outlined below:

        -  Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV).

        -  Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril STS
           lead in the right atrium (RA).

        -  Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex lead
           in the RA.

        -  Group 4: Quadra Assura MP CRT-D with a Durata or Optisure lead in the RV, a Tendril STS
           or Isoflex lead in the RA, and a Quartet lead in the left ventricle (LV).

      Endpoints

      Primary Endpoints

        -  Safety: Freedom from MRI-scan related complications related to the ICD device and/or
           leads from the time of the MRI scan to 1-month post-MRI scan testing.

        -  Effectiveness: Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms
           for RA and RV leads and ≤1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month
           post-MRI scan testing.

        -  Effectiveness: Proportion of leads with a sensing amplitude decrease of ≤ 50% from
           pre-MRI scan testing to 1-month post-MRI scan.

      Descriptive Endpoint(s)

      Descriptive endpoints are reported using only summary statistics and no hypothesis tests will
      be performed.

      The following data will be collected:

        1. Demographics: gender, age, ethnicity, race, cardiac disease history, arrhythmia history,
           indication for ICD implant, history of smoking, etc.

        2. Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1
           Month Post Scan Visit

        3. ADE, SADE, USADE

        4. Mortality

        5. Number of non-study MRI scans

        6. Summarize number of subjects that returned to usual programming after the MRI scan and
           number of subjects, if any, experiencing delays in reprogramming

      This is a prospective, multi-center, single-arm study to evaluate the safety and
      effectiveness of the Ellipse VR/DR ICDs, and the Quadra Assura MP CRT-D, with Durata or
      Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet
      quadripolar LV lead in a 1.5T MRI environment for MR-conditional labeling expansion in China.

      This study will be conducted in at least 6 centers in China and at least 60 subjects who
      provide consent for participation will be enrolled. Subjects will be considered enrolled
      after providing consent. Subjects will be implanted with any one of the device/lead
      combination groups outlined in Figure 1, depending on their clinical need as determined by
      the Investigators. At least 15 subjects will be enrolled in each group.

        -  Group 1 will have at least 15 enrolled subjects with the Ellipse VR single-chamber ICD
           with a Durata lead in the RV.

        -  Group 2 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD
           with a Durata lead in the RV and a Tendril STS lead in the RA.

        -  Group 3 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD
           with a Optisure lead in the RV and a Isoflex lead in the RA.

        -  Group 4 will have at least 15 enrolled subjects with a Quadra Assura MP CRT-D and an
           Optisure or Durata lead in the RV, an Isoflex or Tendril STS lead in the RA, and a
           Quartet lead in the LV.

      The enrollment group and group 4 lead pairing will be at the discretion of the Investigator,
      dependent on patient needs in conjunction with study needs to fulfill study goals.

      At least forty-five (45) days after system implantation or after a system revision, subjects
      will have a baseline visit followed by an MRI visit; subjects will undergo a study-related
      MRI scan at 1.5T. Subjects will have a 1-month follow-up after the study MRI scan. The
      minimum duration of each subject's participation is approximately 2.5 months from enrollment.
      The expected duration of enrollment is approximately 14 months. The total duration of
      clinical study is expected to be 16.5 months.

      The study population includes male and female Chinese nationals that meet the eligibility
      requirements and give consent for the study. Vulnerable subjects, such as minors or those
      unable to provide consent are excluded from participating.

      Inclusion criteria

      Assessment for general eligibility criteria is based on medical records of the site and
      interview with a candidate patient. If some of the clinical and laboratory tests are not
      included in site standard tests, they must be done but after written informed consent is
      obtained. Patients must meet ALL the inclusion criteria to be considered for the clinical
      study. If ANY of the exclusion criteria are met, the patient is excluded from the clinical
      study and cannot be enrolled.

      To participate in this clinical study, the subject must meet all the following inclusion
      criteria:

        -  Have an approved indication for implantation of an ICD, or CRT-D

        -  Be a Chinese national

        -  Will be implanted with one of the following device/lead combinations evaluated in this
           study:

             -  Group 1: Ellipse VR single-chamber ICD with a Durata lead in the RV

             -  Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril
                STS lead in the RA

             -  Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex
                lead in the RA

             -  Group 4: Quadra Assura MP CRT-D and an Optisure or Durata lead in the RV, an
                Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV

        -  Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant
           NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the
           patient can communicate with site personnel during the MRI scan

        -  Be able to provide informed consent for study participation (legal guardian or legally
           authorized representative is NOT acceptable)

        -  Be willing and able to comply with the prescribed follow-up tests and procedures

        -  Are not contraindicated for an MRI scan (per the MRI Screening Form)

        -  Subjects who are at least 18 years of age (or older, required by local law)

      Exclusion criteria

      Subjects who meet any of the following exclusion criteria must be excluded from the clinical
      investigation:

        -  Have a competitor's MRI compatible endocardial lead implanted or capped

        -  Have another existing active implanted medical device, e.g., neurostimulator, infusion
           pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to
           be completed.

        -  Have other non-MRI compatible device or material implanted. The following examples may
           be included as long as labelling of these devices allow MRI scans conducted per this
           protocol:

             -  MRI compatible knee replacements, hip replacements, stents, etc.

             -  MRI compatible mechanical, prosthetic, and bio prosthetic heart valves

             -  Non-removable dental implants

        -  Have a lead extender, adaptor, or capped/abandoned lead

        -  Enrolled or intend to participate in a clinical drug and/or device study
           (investigational device, investigational drug, new indication for a device or drug or
           additional testing beyond standard of care procedures), which could confound the results
           of this study as determined by Abbott.

        -  Pregnant or planning to become pregnant during the duration of the subject's
           participation in the study

        -  Have a life expectancy of less than 12 months due to any condition

      Effectiveness evaluation method

      There are two effectiveness endpoints to be evaluated in this study.

        1. Description of the effectiveness endpoints

             -  Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms for RA and
                RV leads and ≤ 1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month post-MRI
                scan testing.

             -  Proportion leads with a sensing amplitude decrease of ≤ 50% from pre-MRI scan
                testing to 1-month post-MRI scan.

        2. Selection of method and time for evaluation, recording and analysis of the effectiveness
           endpoints Since the objective is to evaluate the effect of MRI exposure for the ICD/
           CRT-D device groups included in this study, the effectiveness parameters were selected
           to compare abnormal changes in device performance from pre- to 1-month post- MRI scan.
           The pre-MRI measurements are collected within the same day prior to the MRI scan. The
           1-month post-MRI scan measurements are collected at 30 days post-MRI scan (within +14
           days) to ensure any effect of the MRI exposure is captured.

      The effectiveness parameters are recorded directly from the device. The device measurements
      will be obtained using the Merlin programmer to interrogate the device during study visits.
      The analysis of the effectiveness parameters will be conducted on all subjects with complete
      data from pre- to 1-month post-MRI scan.

      Safety evaluation method There is one safety primary endpoint to be evaluated in this study.

        1. Description of the safety endpoint Freedom from MRI-scan related complications from the
           time of the MRI scan to 1-month post-MRI scan testing.

        2. Selection of method and time for evaluation, recording and analysis of the safety
           endpoints Since the objective is to evaluate the effect of MRI exposure for the ICD/
           CRT-D device groups included in this study, the safety parameters were selected to
           include only MRI-scan related complications from the time of device programming for an
           MRI scan to 1-month post-MRI scan. An independent physician CEC will adjudicate all
           adverse device effects during this period to determine the relatedness to the MRI scan.

      Safety surveillance within this study and the safety reporting, both performed by the
      investigator, starts as soon as the subject completes the pre-MRI visit testing and the MRI
      Settings have been programmed according to the protocol. The safety surveillance and the
      safety reporting will continue until the last study visit has been performed, the subject is
      deceased, the subject/investigator concludes his participation into the clinical study or the
      subject withdrawal from the clinical study.

      Monitoring plan

      Sponsor and/or designee will monitor the clinical study over its duration according to the
      CIP-specific monitoring plan which will include the planned extent of source data
      verification.

      Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the
      following criteria are met:

        -  The investigator understands and accepts the obligation to conduct the clinical study
           according to the CIP and applicable regulations, and has signed the Clinical Trial
           Agreement.

        -  The Investigator and his/her staff should have sufficient time and facilities to conduct
           the clinical study and should have access to an adequate number of appropriate subjects
           to conduct the clinical study.

        -  Source documentation (including original medical records) must be available to
           substantiate proper informed consent procedures, adherence to CIP procedures, adequate
           reporting and follow-up of adverse events, accuracy of data collected on case report
           forms, and device information.

        -  The Investigator/site will permit access to such records. A monitoring visit sign-in log
           will be maintained at the site. The Investigator will agree to dedicate an adequate
           amount of time to the monitoring process. The Investigator and/or research coordinator
           will be available for monitoring visits. It is expected that the Investigator will
           provide the monitor with a suitable working environment for review of clinical
           study-related documents.

      Statistical considerations

      This study is an observational study to meet the requirements for device approval by the
      National Medical Products Administration (NMPA, previously China FDA). There is no endpoint
      hypotheses testing planned in this study. The endpoints, demographics, safety and device data
      will be summarized using descriptive statistics as outlined in the Statistical Analysis Plan
      (SAP).

      Any major changes to the SAP will be documented in an amendment to the SAP. Less significant
      changes to the planned analyses will be documented in the final report(s).

      Data management

      Study data will be handled according to China Device GCP (Order 25). The Leading PI and
      his/her associated organization (leading Unit) will be responsible for compiling and
      submitting all required reports to governmental agencies.

      Before the submission, Leading PI and his/her associated organization (leading Unit) should
      allow sponsor to have a copy of the above reports for reviewing, and providing comments for
      Leading PI and his/her associated organization consideration.

      Data will be analyzed by the Leading PI and his/her associated organization (leading Unit)
      and/or its affiliates. The Leading PI and his/her associated organization (leading Unit)'s
      also agree that data may be transferred to the Sponsor's locations worldwide and/or any other
      worldwide regulatory authority in support of a market-approval application.
observational model: Case-Only
time perspective: Prospective
measure: Safety outcomes: Freedom from Magnetic Resonance Imaging (MRI) scan related complications
time frame: 1 month
description: Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.
measure: Effectiveness outcomes: Proportion of leads with a capture threshold increase
time frame: 1 month
description: Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1-month post-MRI scan testing.
measure: Demographics: Gender
time frame: 1 month
description: Gender
measure: Demographics:Age
time frame: 1 month
description: Age
measure: Demographics: Ethnicity
time frame: 1 month
description: Ethnicity
measure: Demographics: Race
time frame: 1 month
description: Race
measure: Demographics: Medical History
time frame: 1 month
description: Cardiac disease history, arrhythmia history, indication for ICD implant, history of smoking, etc.
measure: Device electrical measurements
time frame: 1 month
description: Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1 Month Post Scan Visit
measure: Number of Adverse Device Events (ADE)
time frame: 1 month
description: Collect the number of ADEs for analysis
measure: Number of Serious Adverse Device Events (SADE)
time frame: 1 month
description: Collect the number of SADEs for analysis
measure: Number of Unparticipated Serious Adverse Device Events (USADE)
time frame: 1 month
description: Collect the number of USADEs for analysis
measure: Number of Deaths
time frame: 1 month
description: Collect the number of ADEs for Mortality analysis
measure: Number of non-study MRI scans
time frame: 1 month
description: Number of non-study MRI scans
measure: The number of subjects that returned to usual programming
time frame: 1 month
description: The number of subjects that returned to usual programming after the MRI scan and number of subjects, if any, experiencing delays in reprogramming
arm group label: Ellipse VR with Durata
description: Ellipse VR single-chamber ICD with a Durata defibrillation lead
arm group label: Ellipse DR with Durata & Tendril STS
description: Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
arm group label: Ellipse DR with Optisure and Isoflex
description: Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
arm group label: Quadra Assura MP CRT-D
description: Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
intervention type: Other
intervention name: Study MRI scan
description: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
arm group label: Ellipse DR with Durata & Tendril STS
arm group label: Ellipse DR with Optisure and Isoflex
arm group label: Ellipse VR with Durata
arm group label: Quadra Assura MP CRT-D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Tachycardia
sharing ipd: Undecided
ipd description: This has not yet been decided.
submitted: March 10, 2022
returned: June 13, 2022
submitted: March 1, 2023