<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/NCT03039712</url>
  </required_header>
  <id_info>
    <org_study_id>Micra CED Study</org_study_id>
    <nct_id>NCT03039712</nct_id>
  </id_info>
  <brief_title>Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers</brief_title>
  <acronym>Micra CED</acronym>
  <official_title>Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of the study is to meet the CMS mandated Coverage with Evidence&#xD;
      Development requirement in the National Coverage Determination for Leadless Pacemakers as&#xD;
      they apply to Medtronic Micra devices. The study uses administrative claims data of the&#xD;
      Medicare population implanted with single-chamber ventricular pacemakers. Patients are&#xD;
      enrolled through submission of claims or encounter data to CMS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Micra CED study is a study of the Medicare beneficiary population implanted with&#xD;
      single-chamber ventricular pacemakers, and will be executed by analyzing administrative&#xD;
      claims data. The study consists of two primary objectives: estimate the: (1) acute overall&#xD;
      complication rate and (2) the 2-year survival rate of patients implanted with a Micra&#xD;
      leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis&#xD;
      of Micra leadless pacemakers to single-chamber ventricular transvenous pacemakers will be&#xD;
      conducted.&#xD;
&#xD;
      The analysis will be in CMS claims data and is subject to a central IRB. However, individual&#xD;
      hospitals are not engaged in research and local IRB oversight is not necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2027</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>Acute complication rate</measure>
    <time_frame>30 days</time_frame>
    <description>Single-chamber ventricular pacemaker system and/or procedure related complications at 30 days. Acute complications include embolism/thrombosis, event at the puncture site, cardiac effusion/perforation, device-related complication, or other complications following the implantation of a single-chamber ventricular pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The 2-year survival rate of patients implanted with a Micra leadless pacemaker</measure>
    <time_frame>2 years</time_frame>
    <description>Estimate the 2-year survival rate of patients implanted with a Micra leadless pacemaker</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic complication rate</measure>
    <time_frame>6 months</time_frame>
    <description>Chronic complications are a subset of acute complications that may also occur within six months following the implantation of a single-chamber ventricular pacemaker. Single-chamber ventricular pacemaker system and/or procedure related complications at six months. Subjects' administrative claims data will be reviewed to determine the occurrence of a chronic complication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related re-intervention rates</measure>
    <time_frame>2 years</time_frame>
    <description>Device-related re-interventions are procedures associated with the insertion/replacement, revision, or removal of either a leadless or transvenous pacemaker system or components following the index implantation of a single-chamber ventricular pacemaker. Device-related re-intervention rates will be reported at six month intervals for two years following the index implantation of a single-chamber ventricular pacemaker. Subjects' administrative claims data will be reviewed to determine the occurrence of a device-related re-intervention</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">37000</enrollment>
  <condition>Bradycardia</condition>
  <arm_group>
    <arm_group_label>Micra leadless pacemaker therapy</arm_group_label>
    <description>All Medicare patients implanted with Micra leadless pacemaker system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Chamber Transvenous pacemaker</arm_group_label>
    <description>All Medicare patients implanted with full system (e.g. lead and generator) single- chamber ventricular transvenous pacemakers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study cohort will include all Medicare patients with continuous claims data implanted&#xD;
        with a Micra leadless pacemaker or a full-system single-chamber ventricular transvenous&#xD;
        pacemaker in any US location.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Medicare beneficiaries implanted with a leadless pacemaker (CPT 0387T or 33274 or ICD-10&#xD;
        PCS 02HK3NZ) on or after the study start date will be included in the study.&#xD;
&#xD;
        or&#xD;
&#xD;
        • Medicare beneficiaries with implanted with a full system single-chamber ventricular&#xD;
        transvenous pacemaker (CPT 33207 or ICD-10 PCS 0JH605Z or 0JH604Z and 02HK3JZ) on or after&#xD;
        the study start date.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • None&#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>Mikhael El Chami, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bradycardia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03039712
org study id: Micra CED Study
nct id: NCT03039712
lead sponsor: 
has dmc: No
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence
      Development requirement in the National Coverage Determination for Leadless Pacemakers as
      they apply to Medtronic Micra devices. The study uses administrative claims data of the
      Medicare population implanted with single-chamber ventricular pacemakers. Patients are
      enrolled through submission of claims or encounter data to CMS.
Micra CED study is a study of the Medicare beneficiary population implanted with
      single-chamber ventricular pacemakers, and will be executed by analyzing administrative
      claims data. The study consists of two primary objectives: estimate the: (1) acute overall
      complication rate and (2) the 2-year survival rate of patients implanted with a Micra
      leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis
      of Micra leadless pacemakers to single-chamber ventricular transvenous pacemakers will be
      conducted.

      The analysis will be in CMS claims data and is subject to a central IRB. However, individual
      hospitals are not engaged in research and local IRB oversight is not necessary.
observational model: Cohort
time perspective: Prospective
measure: Acute complication rate
time frame: 30 days
description: Single-chamber ventricular pacemaker system and/or procedure related complications at 30 days. Acute complications include embolism/thrombosis, event at the puncture site, cardiac effusion/perforation, device-related complication, or other complications following the implantation of a single-chamber ventricular pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.
measure: The 2-year survival rate of patients implanted with a Micra leadless pacemaker
time frame: 2 years
description: Estimate the 2-year survival rate of patients implanted with a Micra leadless pacemaker
measure: Chronic complication rate
time frame: 6 months
description: Chronic complications are a subset of acute complications that may also occur within six months following the implantation of a single-chamber ventricular pacemaker. Single-chamber ventricular pacemaker system and/or procedure related complications at six months. Subjects' administrative claims data will be reviewed to determine the occurrence of a chronic complication.
measure: Device-related re-intervention rates
time frame: 2 years
description: Device-related re-interventions are procedures associated with the insertion/replacement, revision, or removal of either a leadless or transvenous pacemaker system or components following the index implantation of a single-chamber ventricular pacemaker. Device-related re-intervention rates will be reported at six month intervals for two years following the index implantation of a single-chamber ventricular pacemaker. Subjects' administrative claims data will be reviewed to determine the occurrence of a device-related re-intervention
arm group label: Micra leadless pacemaker therapy
description: All Medicare patients implanted with Micra leadless pacemaker system
arm group label: Single Chamber Transvenous pacemaker
description: All Medicare patients implanted with full system (e.g. lead and generator) single- chamber ventricular transvenous pacemakers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mikhael El Chami, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bradycardia
sharing ipd: No