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/NCT06018818</url>
    </required_header>
    <id_info>
      <org_study_id>BA114</org_study_id>
      <nct_id>NCT06018818</nct_id>
    </id_info>
    <brief_title>Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family</brief_title>
    <official_title>BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biotronik SE &amp; Co. KG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Biotronik SE &amp; Co. KG</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>
        The study is designed as an open-label, prospective, international, multicenter,&#xD;
        non-randomized study to determine safety and product performance of the CE-marked&#xD;
        Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in&#xD;
        the setting of a post-market clinical follow-up study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
    <phase>N/A</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>SADE-free rate at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SADE-free rate at 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CRT AutoAdapt performance</measure>
      <time_frame>12 months</time_frame>
      <description>CRT AutoAdapt: different pacing percentages</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CRT AutoAdapt AV delay</measure>
      <time_frame>12 months</time_frame>
      <description>Mean adapted AV delay after pace/sense</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator</measure>
      <time_frame>12 months</time_frame>
      <description>Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Auto LV VectorOpt</measure>
      <time_frame>12 months</time_frame>
      <description>Time needed for threshold measurement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator</measure>
      <time_frame>2 months</time_frame>
      <description>Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>aATP-related ADEs and SADEs</measure>
      <time_frame>12 months</time_frame>
      <description>aATP-related ADEs and SADEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensing performance of device-based measurements</measure>
      <time_frame>12 months</time_frame>
      <description>The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pacing performance of device-based measurements</measure>
      <time_frame>12 months</time_frame>
      <description>The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">125</enrollment>
    <condition>Bradycardia</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Amvia pacemaker or CRT-P implantation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Amvia/Solvia pacemaker family</intervention_name>
      <description>Implantation of a pacemaker or CRT-P devices</description>
      <arm_group_label>Amvia pacemaker or CRT-P implantation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Standard indication for de novo, upgrade or replacement pacemaker or cardiac&#xD;
               resynchronization therapy pacemaker (CRT-P) implantation&#xD;
  &#xD;
            -  Ability to understand the nature of the study&#xD;
  &#xD;
            -  Willingness to provide written informed consent&#xD;
  &#xD;
            -  Ability and willingness to perform all follow-up visits at the study site&#xD;
  &#xD;
            -  Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK&#xD;
               Home Monitoring® concept&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Planned for conduction system pacing&#xD;
  &#xD;
            -  Planned cardiac surgical procedures or interventional measures other than the study&#xD;
               procedure within the next 12 months&#xD;
  &#xD;
            -  Known pregnancy or breast feeding&#xD;
  &#xD;
            -  Age less than 18 years&#xD;
  &#xD;
            -  Participation in another interventional clinical investigation&#xD;
  &#xD;
            -  Life-expectancy less than 12 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Istvan Szendey, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kliniken Maria Hilf GmbH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dörte Vossmeyer, Dr.</last_name>
      <phone>+49 30 68905 1306</phone>
      <email>doerte.vossmeyer@biotronik.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Konstantinia Skreka, Dr.</last_name>
      <phone>+49 (0) 30 68905-2949</phone>
      <email>konstantinia.skreka@biotronik.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>
  
  
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/NCT06018818
  org study id: BA114
  nct id: NCT06018818
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is designed as an open-label, prospective, international, multicenter,
        non-randomized study to determine safety and product performance of the CE-marked
        Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in
        the setting of a post-market clinical follow-up study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: SADE-free rate at 6 months
  time frame: 6 months
  description: Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
  measure: SADE-free rate at 12 months
  time frame: 12 months
  description: Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
  measure: CRT AutoAdapt performance
  time frame: 12 months
  description: CRT AutoAdapt: different pacing percentages
  measure: CRT AutoAdapt AV delay
  time frame: 12 months
  description: Mean adapted AV delay after pace/sense
  measure: Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
  time frame: 12 months
  description: Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
  measure: Auto LV VectorOpt
  time frame: 12 months
  description: Time needed for threshold measurement
  measure: Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
  time frame: 2 months
  description: Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
  measure: aATP-related ADEs and SADEs
  time frame: 12 months
  description: aATP-related ADEs and SADEs
  measure: Sensing performance of device-based measurements
  time frame: 12 months
  description: The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.
  measure: Pacing performance of device-based measurements
  time frame: 12 months
  description: The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.
  arm group label: Amvia pacemaker or CRT-P implantation
  arm group type: Other
  intervention type: Device
  intervention name: Amvia/Solvia pacemaker family
  description: Implantation of a pacemaker or CRT-P devices
  arm group label: Amvia pacemaker or CRT-P implantation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Istvan Szendey, Dr.
  role: Principal Investigator
  affiliation: Kliniken Maria Hilf GmbH
  last name: Dörte Vossmeyer, Dr.
  phone: +49 30 68905 1306
  email: doerte.vossmeyer@biotronik.com
  last name: Konstantinia Skreka, Dr.
  phone: +49 (0) 30 68905-2949
  email: konstantinia.skreka@biotronik.com
  responsible party type: Sponsor
  mesh term: Bradycardia
  sharing ipd: No