<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/NCT02994667</url>
  </required_header>
  <id_info>
    <org_study_id>014-286</org_study_id>
    <nct_id>NCT02994667</nct_id>
  </id_info>
  <brief_title>Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)</brief_title>
  <acronym>PPM in TAVR</acronym>
  <official_title>Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in&#xD;
      patients undergoing permanent pacemaker placement after TAVR.&#xD;
&#xD;
      As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular&#xD;
      conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing&#xD;
      permanent pacemaker placement after TAVR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Development of atrioventricular (AV) conduction system abnormalities requiring placement of a&#xD;
      permanent pacemaker (PPM) is a known complication of transcatheter aortic valve replacement&#xD;
      (TAVR). Male gender, pre-existing AV conduction system abnormalities, transient AV block&#xD;
      intra-procedurally, and use of a self-expanding valve have all been associated with increased&#xD;
      risk of AV block and need for permanent pacemaker placement. Persistent AV conduction&#xD;
      abnormalities have been documented in approximately 15% of patients who receive an Edwards&#xD;
      Sapien valve, with 4% requiring permanent pacemaker placement. 22-28% of patients who receive&#xD;
      a CoreValve require permanent pacemaker placement in some studies. In one study, 78% of&#xD;
      patients who underwent His bundle electrogram assessment during CoreValve placement had&#xD;
      transient or persistent AV conduction system abnormalities during the procedure.&#xD;
&#xD;
      Pacemakers placed at The Heart Hospital Baylor Plano are produced by two manufactures:&#xD;
      Medtronic, Inc. and St. Jude Medical, Inc. Each of these manufacturers have pacemakers with&#xD;
      algorithms designed to minimize right ventricular pacing. Medtronic's algorithm is referred&#xD;
      to as &quot;MVP&quot; (Managed Ventricular Pacing), and St. Jude Medical's algorithm is referred to as&#xD;
      &quot;VIP&quot; (Ventricular Intrinsic Preference). Each of these techniques purports to reduce&#xD;
      unnecessary right ventricular (RV) pacing through a novel pacemaker algorithm. Both&#xD;
      manufacturers' pacemaker programmers and remote monitoring systems allow for demonstration of&#xD;
      the percentage of ventricular pacing performed by the device.&#xD;
&#xD;
      The Investigators propose to assess the 90 day- ventricular pacing, atrioventricular block&#xD;
      (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate&#xD;
      histogram incidence in those patients who undergo pacemaker implantation due to elevated risk&#xD;
      (or occurrence of) high-grade AV block after TAVR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Ventricular Pacing</measure>
    <time_frame>7-90 days</time_frame>
    <description>Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of other conduction disturbances</measure>
    <time_frame>7-90 days</time_frame>
    <description>Freedom from documented atrioventricular block (AVB), intraventricular conduction dely (IVCD), bundle branch block (BBB) as indicated by pacemaker interrogation or remote monitoring system.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Ventricular Flutter</condition>
  <condition>Atrioventricular Block</condition>
  <condition>Intraventricular Conduction Delay</condition>
  <condition>Bundle Branch Block</condition>
  <condition>Pacemaker Implantation</condition>
  <arm_group>
    <arm_group_label>Pacemaker After TAVR</arm_group_label>
    <description>The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Permanent Pacemaker Placement</intervention_name>
    <arm_group_label>Pacemaker After TAVR</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study cohort will comprise all consecutive patients who undergo permanent pacemaker&#xD;
        placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and&#xD;
        12/31/2016 and will consist of up to 50 patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age&#xD;
&#xD;
          -  Patients undergoing Transcatheter Aortic Valve Replacement&#xD;
&#xD;
          -  Indication for PPM including:&#xD;
&#xD;
               1. Persistent 3rd degree AVB&#xD;
&#xD;
               2. Transient 3rd degree AVB&#xD;
&#xD;
               3. New Left BBB&#xD;
&#xD;
               4. New bifascicular block&#xD;
&#xD;
               5. New first degree AV block&#xD;
&#xD;
               6. Any conduction disturbance determined by the investigator to be related to the&#xD;
                  TAVR procedure 4. Patients receiving post-TAVR PPM with one of the following&#xD;
                  devices&#xD;
&#xD;
             a. Medtronic: i. ADAPTA DR -ADDR01 ii. ADAPTA L DR-ADDRL1 iii. ADVISA MRI-A2DR01 b.&#xD;
             St. Jude Medical: i. Zypher 5820 ii. Zypher 5826 iii. Accent pm2110 iv. Accent pm2210&#xD;
             v. Assurity pm2240 vi. Endurity Pm2160&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy-Women of childbearing potential should have negative urine 'pregnancy test&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Patients with implanted pacemaker&#xD;
&#xD;
          -  Patients with implantable cardiac defibrillator&#xD;
&#xD;
          -  Indication for post TAVR PPM not related to the procedure including sinus node&#xD;
             dysfunction/sick sinus syndrome.&#xD;
&#xD;
          -  Medically unable to provide consent&#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_official>
    <last_name>Brian Deville, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Heart Hospital Baylor of Plano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Heart Hospital Baylor of Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 19, 2020</last_update_submitted>
  <last_update_submitted_qc>January 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electrophysiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bundle-Branch Block</mesh_term>
    <mesh_term>Atrioventricular Block</mesh_term>
    <mesh_term>Ventricular Flutter</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data on the clinical and non-clinical risk factors will be summarized using means, standard deviations (SDs) and percentages. The Kaplan-Meier method will be used to construct a ventricular pacing free curve summarizing time-to ventricular pacing incidence in the study cohort -the competing risk of death will be accounted in the analysis.</ipd_description>
  </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/NCT02994667
org study id: 014-286
nct id: NCT02994667
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in
      patients undergoing permanent pacemaker placement after TAVR.

      As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular
      conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing
      permanent pacemaker placement after TAVR.
Development of atrioventricular (AV) conduction system abnormalities requiring placement of a
      permanent pacemaker (PPM) is a known complication of transcatheter aortic valve replacement
      (TAVR). Male gender, pre-existing AV conduction system abnormalities, transient AV block
      intra-procedurally, and use of a self-expanding valve have all been associated with increased
      risk of AV block and need for permanent pacemaker placement. Persistent AV conduction
      abnormalities have been documented in approximately 15% of patients who receive an Edwards
      Sapien valve, with 4% requiring permanent pacemaker placement. 22-28% of patients who receive
      a CoreValve require permanent pacemaker placement in some studies. In one study, 78% of
      patients who underwent His bundle electrogram assessment during CoreValve placement had
      transient or persistent AV conduction system abnormalities during the procedure.

      Pacemakers placed at The Heart Hospital Baylor Plano are produced by two manufactures:
      Medtronic, Inc. and St. Jude Medical, Inc. Each of these manufacturers have pacemakers with
      algorithms designed to minimize right ventricular pacing. Medtronic's algorithm is referred
      to as "MVP" (Managed Ventricular Pacing), and St. Jude Medical's algorithm is referred to as
      "VIP" (Ventricular Intrinsic Preference). Each of these techniques purports to reduce
      unnecessary right ventricular (RV) pacing through a novel pacemaker algorithm. Both
      manufacturers' pacemaker programmers and remote monitoring systems allow for demonstration of
      the percentage of ventricular pacing performed by the device.

      The Investigators propose to assess the 90 day- ventricular pacing, atrioventricular block
      (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate
      histogram incidence in those patients who undergo pacemaker implantation due to elevated risk
      (or occurrence of) high-grade AV block after TAVR.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Ventricular Pacing
time frame: 7-90 days
description: Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system.
measure: Incidence of other conduction disturbances
time frame: 7-90 days
description: Freedom from documented atrioventricular block (AVB), intraventricular conduction dely (IVCD), bundle branch block (BBB) as indicated by pacemaker interrogation or remote monitoring system.
arm group label: Pacemaker After TAVR
description: The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016.
intervention type: Device
intervention name: Permanent Pacemaker Placement
arm group label: Pacemaker After TAVR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Deville, MD
role: Principal Investigator
affiliation: The Heart Hospital Baylor of Plano
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bundle-Branch Block
mesh term: Atrioventricular Block
mesh term: Ventricular Flutter
sharing ipd: Yes
ipd description: Data on the clinical and non-clinical risk factors will be summarized using means, standard deviations (SDs) and percentages. The Kaplan-Meier method will be used to construct a ventricular pacing free curve summarizing time-to ventricular pacing incidence in the study cohort -the competing risk of death will be accounted in the analysis.