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/NCT05966168</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00112840</org_study_id>
      <nct_id>NCT05966168</nct_id>
    </id_info>
    <brief_title>Micra AV Tracking During Exercise Testing</brief_title>
    <official_title>Tracking of Mechanically Sensed Atrial Activity During Exercise Using a Leadless Transcatheter Pacing System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during&#xD;
        exercise or elevated heart rates. Participation in research studies is voluntary. In this&#xD;
        study, participants will already be planned to have a Micra AV 2.0 device implanted.&#xD;
        Participants will then undergo treadmill exercise testing and wear a Holter monitor. For each&#xD;
        participant, the tracking performance of the Micra AV 2.0 will be evaluated at rest and&#xD;
        during exercise. Follow up visits will occur as part of standard of care and each participant&#xD;
        will be enrolled in the study for up to 6 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be screened and eligible participants who express informed consent will&#xD;
        complete exercise testing and holter monitoring. For each participant, the tracking&#xD;
        performance of the atrial mechanically sensed, ventricular pacing device will be assessed at&#xD;
        rest and during exercise using exercise testing. For each test, the sinus rate trend will be&#xD;
        recorded alongside the presence or absence of a mechanically sensed ventricular paced event&#xD;
        (AM-VP) for each sinus beat. The average tracking index in each phase of exercise testing -&#xD;
        rest, exercise, and recovery - and across the spectrum of achieved heart rates across the&#xD;
        cohort will be calculated and reported. Holter monitoring will also be used to assess&#xD;
        tracking index across the spectrum of heart rates achieved during routine daily activities&#xD;
        across a 24 hour period.&#xD;
  &#xD;
        After enrollment, the following baseline information will be assimilated from the medical&#xD;
        record and will be collected if not already done based on routine clinical care: date of&#xD;
        pacemaker implant, pacemaker implant location (high septum, mid septum, apex), cardiac&#xD;
        disease history, and programmed pacemaker parameters.&#xD;
  &#xD;
        Exercise testing will be performed between one week and six months after Micra AV implant.&#xD;
        Participants will complete preparation for exercise testing according to institutional&#xD;
        standards. Participants will be given instructions to take all prescribed medications,&#xD;
        including antiarrhythmic drugs and AV nodal blocking agents, according to their usual&#xD;
        schedule, including on the day of the test.&#xD;
  &#xD;
        Participants will be provided with a holter monitor. Participants will begin wearing the&#xD;
        monitor during the rest period at the start of the exercise testing protocol. Exercise&#xD;
        testing will be completed using standardized Micra AV device programming settings: VDD mode&#xD;
        with nominal maximal tracking rate. Auto programming will be used to initialize device&#xD;
        parameter selection. Following completion of auto programming, a MAM test will be performed&#xD;
        to assess atrial signal discrimination. A fixed A3 discrimination threshold will then be&#xD;
        selected which is approximately 1.0 m/s2 greater than the isolated accelerometer A3 signal.10&#xD;
        Other sensing parameters will be adjusted as clinically indicated to optimize atrial signal&#xD;
        discrimination. Each participant will undergo device monitoring accompanied by external&#xD;
        telemetry for 20 minutes at rest, followed by a fitness level-appropriate standardized stress&#xD;
        protocol (e.g., Bruce protocol, Naughton protocol, Eckland protocol) on the treadmill or&#xD;
        recumbent bicycle. They will perform graded exercise until achieving a heart rate of 130 bpm,&#xD;
        or until physical fatigue, limiting chest pain (or discomfort), marked ischemia, or a drop in&#xD;
        blood pressure occur (if such symptoms develop prior to reaching the target heart rate),&#xD;
        supervised by a clinician experienced in performing cardiac stress testing. Once reaching 130&#xD;
        bpm, participants will remain at the current stage on their exercise protocol until physical&#xD;
        fatigue, limiting chest pain (or discomfort), marked ischemia, or a drop in blood pressure&#xD;
        occurs, or up to a maximum of twenty total minutes of exercise. Participants will be asked to&#xD;
        report level of perceived exertion and fatigue level at pre-determined intervals. Cardiac&#xD;
        rhythm will be recorded using 12-lead telemetry throughout the rest, exercise, and recovery&#xD;
        periods. If the tracking index during exercise is lower than 70%, atrial sensing will be&#xD;
        optimized using a MAM test.&#xD;
  &#xD;
        The following data will be collected during exercise testing: exercise protocol utilized,&#xD;
        protocol stage achieved, baseline cardiac rhythm, characterization of atrial and/or&#xD;
        ventricular tachyarrhythmias, resting heart rate, peak heart rate, peak blood pressure,&#xD;
        perceived level of exertion and fatigue, total exercise time, total metabolic equivalents&#xD;
        (METs) achieved, and reason for termination.&#xD;
  &#xD;
        The following data will be abstracted from device interrogation and 12-lead telemetry&#xD;
        following the test: total number of sinus atrial beats, total number of premature atrial&#xD;
        complexes (PAC), total number of premature ventricular complexes (PVC), number of tracked&#xD;
        events, number of non-tracked ventricular paced events, and number of ventricular beats&#xD;
        resulting from native AV conduction. Participants will continue to wear the provided holter&#xD;
        monitor for the remainder of the 24 hour period. The following data will be collected during&#xD;
        holter monitoring: average heart rate, peak heart rate, minimum heart rate, characterization&#xD;
        of atrial and/or ventricular tachyarrhythmias, total number of sinus atrial beats, total&#xD;
        number of premature atrial complexes (PAC), total number of premature ventricular complexes&#xD;
        (PVC), number of tracked events, number of non-tracked ventricular paced events, and number&#xD;
        of ventricular beats resulting from native AV conduction. Patient charts will be reviewed at&#xD;
        the time of study completion to report clinical outcomes including death, device extraction,&#xD;
        and/or transition to a transvenous pacing system.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
    <phase>Phase 4</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average tracking index at rest</measure>
      <time_frame>6 months</time_frame>
      <description>Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average tracking index during exercise</measure>
      <time_frame>6 months</time_frame>
      <description>Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average tracking index during recovery</measure>
      <time_frame>6 months</time_frame>
      <description>Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Average total AV synchrony at rest</measure>
      <time_frame>6 months</time_frame>
      <description>Calculated as AM-VP percentage plus AM-VS percentage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average total AV synchrony during exercise</measure>
      <time_frame>6 months</time_frame>
      <description>Calculated as AM-VP percentage plus AM-VS percentage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average total AV synchrony during recovery</measure>
      <time_frame>6 months</time_frame>
      <description>Calculated as AM-VP percentage plus AM-VS percentage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average tracking index</measure>
      <time_frame>6 months</time_frame>
      <description>The average tracking index across the spectrum of achieved heart rates across the cohort, categorized in 10-bpm ranges, from 55 bpm to 135 bpm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average total AV synchrony</measure>
      <time_frame>6 months</time_frame>
      <description>The average total AV synchrony across the spectrum of achieved heart rates across the cohort, categorized in 10-bpm ranges, from 55 bpm to 135 bpm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device programming features among those with tracking index &gt;70%</measure>
      <time_frame>6 months</time_frame>
      <description>Percent of patients using auto threshold and window modes, and average A3 window, A3 threshold, A4 window, and A4 threshold values.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical and device features which differentiate those with low tracking index</measure>
      <time_frame>6 months</time_frame>
      <description>Clinical and device features which differentiate those with low tracking index (&lt;70% tracking with ≥20% ventricular pacing) during the initial exercise test from those with high tracking index (if such a subset of patients exists).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average tracking index during holter monitoring</measure>
      <time_frame>6 months</time_frame>
      <description>• Average tracking index during holter monitoring across the spectrum of achieved heart rates across the cohort, categorized in 10-bpm ranges, from 55 bpm to 135 bpm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timeframe of optimal programing</measure>
      <time_frame>6 months</time_frame>
      <description>Time (minutes) required to optimize programming prior to exercise testing.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Heart Block AV</condition>
    <arm_group>
      <arm_group_label>Micra AV Exercise Testing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will have Micra AV 2.0 implanted then undergo exercise testing while wearing Holter Monitor</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Medtronic Micra AV Device</intervention_name>
      <description>Participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates.</description>
      <arm_group_label>Micra AV Exercise Testing</arm_group_label>
      <other_name>Micra AV Tracking During Exercise</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Presence of a Micra AV leadless pacemaker with the Micra AV 2.0 algorithm and at least&#xD;
               50% RV pacing&#xD;
  &#xD;
            -  High grade atrioventricular heart block as the primary indication for permanent pacing&#xD;
  &#xD;
            -  Sinus rhythm&#xD;
  &#xD;
            -  Physical ability to walk on a treadmill or ride a recumbent bicycle for exercise&#xD;
               testing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Earlier version of the Micra leadless pacemaker&#xD;
  &#xD;
            -  Intact atrioventricular conduction&#xD;
  &#xD;
            -  Persistent atrial fibrillation&#xD;
  &#xD;
            -  Those with absolute contraindications to exercise testing:&#xD;
  &#xD;
            -  Acute myocardial infarction (MI) within 2 days&#xD;
  &#xD;
            -  Ongoing unstable angina&#xD;
  &#xD;
            -  Uncontrolled cardiac arrhythmia with hemodynamic compromise&#xD;
  &#xD;
            -  Active endocarditis&#xD;
  &#xD;
            -  Symptomatic severe aortic stenosis&#xD;
  &#xD;
            -  Decompensated heart failure&#xD;
  &#xD;
            -  Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis&#xD;
  &#xD;
            -  Acute myocarditis or pericarditis&#xD;
  &#xD;
            -  Acute aortic dissection&#xD;
  &#xD;
            -  Physical disability that precludes safe and adequate testing&#xD;
  &#xD;
            -  Inability to consent&#xD;
  &#xD;
            -  Patient refusal to participate&#xD;
  &#xD;
            -  Pregnant patients&#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_official>
      <last_name>Camille Frazier-Mills</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke Medicine - Cardiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Meghan Pergola</last_name>
      <phone>919-681-8983</phone>
      <email>meghan.pergola@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elyse Wilson</last_name>
      <phone>919-681-8879</phone>
      <email>elyse.wilson@duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Duke University Health System</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Meghan Pergola</last_name>
        <phone>919-681-8983</phone>
      </contact>
      <contact_backup>
        <last_name>Elyse Wilson</last_name>
        <phone>919-681-8879</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AV Heart Block</keyword>
    <keyword>High-grade Heart Block</keyword>
    <keyword>MICRA AV</keyword>
    <keyword>Medtronic</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Block</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05966168
  org study id: Pro00112840
  nct id: NCT05966168
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during
        exercise or elevated heart rates. Participation in research studies is voluntary. In this
        study, participants will already be planned to have a Micra AV 2.0 device implanted.
        Participants will then undergo treadmill exercise testing and wear a Holter monitor. For each
        participant, the tracking performance of the Micra AV 2.0 will be evaluated at rest and
        during exercise. Follow up visits will occur as part of standard of care and each participant
        will be enrolled in the study for up to 6 months.
  Participants will be screened and eligible participants who express informed consent will
        complete exercise testing and holter monitoring. For each participant, the tracking
        performance of the atrial mechanically sensed, ventricular pacing device will be assessed at
        rest and during exercise using exercise testing. For each test, the sinus rate trend will be
        recorded alongside the presence or absence of a mechanically sensed ventricular paced event
        (AM-VP) for each sinus beat. The average tracking index in each phase of exercise testing -
        rest, exercise, and recovery - and across the spectrum of achieved heart rates across the
        cohort will be calculated and reported. Holter monitoring will also be used to assess
        tracking index across the spectrum of heart rates achieved during routine daily activities
        across a 24 hour period.
  
        After enrollment, the following baseline information will be assimilated from the medical
        record and will be collected if not already done based on routine clinical care: date of
        pacemaker implant, pacemaker implant location (high septum, mid septum, apex), cardiac
        disease history, and programmed pacemaker parameters.
  
        Exercise testing will be performed between one week and six months after Micra AV implant.
        Participants will complete preparation for exercise testing according to institutional
        standards. Participants will be given instructions to take all prescribed medications,
        including antiarrhythmic drugs and AV nodal blocking agents, according to their usual
        schedule, including on the day of the test.
  
        Participants will be provided with a holter monitor. Participants will begin wearing the
        monitor during the rest period at the start of the exercise testing protocol. Exercise
        testing will be completed using standardized Micra AV device programming settings: VDD mode
        with nominal maximal tracking rate. Auto programming will be used to initialize device
        parameter selection. Following completion of auto programming, a MAM test will be performed
        to assess atrial signal discrimination. A fixed A3 discrimination threshold will then be
        selected which is approximately 1.0 m/s2 greater than the isolated accelerometer A3 signal.10
        Other sensing parameters will be adjusted as clinically indicated to optimize atrial signal
        discrimination. Each participant will undergo device monitoring accompanied by external
        telemetry for 20 minutes at rest, followed by a fitness level-appropriate standardized stress
        protocol (e.g., Bruce protocol, Naughton protocol, Eckland protocol) on the treadmill or
        recumbent bicycle. They will perform graded exercise until achieving a heart rate of 130 bpm,
        or until physical fatigue, limiting chest pain (or discomfort), marked ischemia, or a drop in
        blood pressure occur (if such symptoms develop prior to reaching the target heart rate),
        supervised by a clinician experienced in performing cardiac stress testing. Once reaching 130
        bpm, participants will remain at the current stage on their exercise protocol until physical
        fatigue, limiting chest pain (or discomfort), marked ischemia, or a drop in blood pressure
        occurs, or up to a maximum of twenty total minutes of exercise. Participants will be asked to
        report level of perceived exertion and fatigue level at pre-determined intervals. Cardiac
        rhythm will be recorded using 12-lead telemetry throughout the rest, exercise, and recovery
        periods. If the tracking index during exercise is lower than 70%, atrial sensing will be
        optimized using a MAM test.
  
        The following data will be collected during exercise testing: exercise protocol utilized,
        protocol stage achieved, baseline cardiac rhythm, characterization of atrial and/or
        ventricular tachyarrhythmias, resting heart rate, peak heart rate, peak blood pressure,
        perceived level of exertion and fatigue, total exercise time, total metabolic equivalents
        (METs) achieved, and reason for termination.
  
        The following data will be abstracted from device interrogation and 12-lead telemetry
        following the test: total number of sinus atrial beats, total number of premature atrial
        complexes (PAC), total number of premature ventricular complexes (PVC), number of tracked
        events, number of non-tracked ventricular paced events, and number of ventricular beats
        resulting from native AV conduction. Participants will continue to wear the provided holter
        monitor for the remainder of the 24 hour period. The following data will be collected during
        holter monitoring: average heart rate, peak heart rate, minimum heart rate, characterization
        of atrial and/or ventricular tachyarrhythmias, total number of sinus atrial beats, total
        number of premature atrial complexes (PAC), total number of premature ventricular complexes
        (PVC), number of tracked events, number of non-tracked ventricular paced events, and number
        of ventricular beats resulting from native AV conduction. Patient charts will be reviewed at
        the time of study completion to report clinical outcomes including death, device extraction,
        and/or transition to a transvenous pacing system.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Average tracking index at rest
  time frame: 6 months
  description: Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.
  measure: Average tracking index during exercise
  time frame: 6 months
  description: Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.
  measure: Average tracking index during recovery
  time frame: 6 months
  description: Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.
  measure: Average total AV synchrony at rest
  time frame: 6 months
  description: Calculated as AM-VP percentage plus AM-VS percentage.
  measure: Average total AV synchrony during exercise
  time frame: 6 months
  description: Calculated as AM-VP percentage plus AM-VS percentage.
  measure: Average total AV synchrony during recovery
  time frame: 6 months
  description: Calculated as AM-VP percentage plus AM-VS percentage.
  measure: Average tracking index
  time frame: 6 months
  description: The average tracking index across the spectrum of achieved heart rates across the cohort, categorized in 10-bpm ranges, from 55 bpm to 135 bpm.
  measure: Average total AV synchrony
  time frame: 6 months
  description: The average total AV synchrony across the spectrum of achieved heart rates across the cohort, categorized in 10-bpm ranges, from 55 bpm to 135 bpm.
  measure: Device programming features among those with tracking index >70%
  time frame: 6 months
  description: Percent of patients using auto threshold and window modes, and average A3 window, A3 threshold, A4 window, and A4 threshold values.
  measure: Clinical and device features which differentiate those with low tracking index
  time frame: 6 months
  description: Clinical and device features which differentiate those with low tracking index (<70% tracking with ≥20% ventricular pacing) during the initial exercise test from those with high tracking index (if such a subset of patients exists).
  measure: Average tracking index during holter monitoring
  time frame: 6 months
  description: • Average tracking index during holter monitoring across the spectrum of achieved heart rates across the cohort, categorized in 10-bpm ranges, from 55 bpm to 135 bpm.
  measure: Timeframe of optimal programing
  time frame: 6 months
  description: Time (minutes) required to optimize programming prior to exercise testing.
  arm group label: Micra AV Exercise Testing
  arm group type: Experimental
  description: All participants will have Micra AV 2.0 implanted then undergo exercise testing while wearing Holter Monitor
  intervention type: Device
  intervention name: Medtronic Micra AV Device
  description: Participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates.
  arm group label: Micra AV Exercise Testing
  other name: Micra AV Tracking During Exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Camille Frazier-Mills
  role: Principal Investigator
  affiliation: Duke Medicine - Cardiology
  last name: Meghan Pergola
  phone: 919-681-8983
  email: meghan.pergola@duke.edu
  last name: Elyse Wilson
  phone: 919-681-8879
  email: elyse.wilson@duke.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Block
  sharing ipd: No