<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/NCT01725568</url>
  </required_header>
  <id_info>
    <org_study_id>60</org_study_id>
    <nct_id>NCT01725568</nct_id>
  </id_info>
  <brief_title>BioMonitor Master Study</brief_title>
  <acronym>BioMonitor</acronym>
  <official_title>Master Study of the Implantable Cardiac Monitor &quot;BioMonitor&quot;</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The BioMonitor is an implantable cardiac monitor used to automatically detect and record&#xD;
      episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial&#xD;
      fibrillation. The study will be conducted to support regulatory approvals outside of Europe.&#xD;
      This BioMonitor Master study is designed to investigate the clinical efficacy and safety of&#xD;
      the BioMonitor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>SADE free-rate</measure>
    <time_frame>at 3 month follow-up</time_frame>
    <description>SADE free-rate &gt; 90% at 3 month follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of appropriate QRS detection</measure>
    <time_frame>at 6 week follow-up</time_frame>
    <description>Rate of appropriate QRS detection &gt; 90% (based on comparison with Holter ECG recording)</description>
  </primary_outcome>
  <other_outcome>
    <measure>Sensitivity and Positive Predictive of episode detection</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity and Positive Predictive Value of each automatically detected cardiac arrhythmia that was stored as subcutaneous electrocardiogram by the BioMonitor (6 week, 3 and 12 month follow-up data)</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>ATRIAL FIBRILLATION, Syncope</condition>
  <arm_group>
    <arm_group_label>Implantable cardiac monitor diagnostics</arm_group_label>
    <description>Patients has standard indication for implantable cardiac monitor diagnostic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioMonitor</intervention_name>
    <description>Implantable cardiac monitor</description>
    <arm_group_label>Implantable cardiac monitor diagnostics</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with standard ICM indication who are referred to the hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after&#xD;
             ablation procedure OR Stroke of unknown origin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Implanted ICD or cardiac pacemaker&#xD;
&#xD;
          -  Allergy to patch electrodes&#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>Dietmar Baensch, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rostock, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</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>Syncope</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01725568
org study id: 60
nct id: NCT01725568
lead sponsor: 
has dmc: No
The BioMonitor is an implantable cardiac monitor used to automatically detect and record
      episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial
      fibrillation. The study will be conducted to support regulatory approvals outside of Europe.
      This BioMonitor Master study is designed to investigate the clinical efficacy and safety of
      the BioMonitor.
observational model: Case-Only
time perspective: Prospective
measure: SADE free-rate
time frame: at 3 month follow-up
description: SADE free-rate > 90% at 3 month follow-up
measure: Rate of appropriate QRS detection
time frame: at 6 week follow-up
description: Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording)
measure: Sensitivity and Positive Predictive of episode detection
time frame: 1 year
description: Sensitivity and Positive Predictive Value of each automatically detected cardiac arrhythmia that was stored as subcutaneous electrocardiogram by the BioMonitor (6 week, 3 and 12 month follow-up data)
measure: Adverse events
time frame: 1 year
arm group label: Implantable cardiac monitor diagnostics
description: Patients has standard indication for implantable cardiac monitor diagnostic.
intervention type: Device
intervention name: BioMonitor
description: Implantable cardiac monitor
arm group label: Implantable cardiac monitor diagnostics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dietmar Baensch, Professor
role: Principal Investigator
affiliation: University of Rostock, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Syncope
mesh term: Atrial Fibrillation