<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/NCT01711281</url>
  </required_header>
  <id_info>
    <org_study_id>CR010</org_study_id>
    <nct_id>NCT01711281</nct_id>
  </id_info>
  <brief_title>Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement</brief_title>
  <acronym>BIODetectHFII</acronym>
  <official_title>Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement</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>
      Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major&#xD;
      cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for&#xD;
      synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters,&#xD;
      physical capacity and quality of life. A continuous measurement of the left-ventricular&#xD;
      volume would provide information about heart performance and could be used for both heart&#xD;
      failure monitoring and optimization of CRT-therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">June 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).</measure>
    <time_frame>Month 2</time_frame>
    <description>SV will be assessed using Echo Doppler Ao-VTI (Aortic velocity time integral). SZ will be measured in parallel using intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).</measure>
    <time_frame>Month 2</time_frame>
    <description>LVESV will be assessed using echo Biplane Simpson's method. LVESZ will be measured using the intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).</measure>
    <time_frame>Month 2</time_frame>
    <description>SV will be assessed using a non-invasive blood pressure measurement device. SZ will be measured using the intracardiac impedance measurement.The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Intracardiac Impedance Measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)</intervention_name>
    <arm_group_label>Intracardiac Impedance Measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  De novo CRT-patients&#xD;
&#xD;
          -  Planned implantation with a Lumax 740 HF-T device, a bipolar LV-lead and a true&#xD;
             bipolar RV-lead&#xD;
&#xD;
          -  NYHA class II or III&#xD;
&#xD;
          -  QRS ≥ 150 ms&#xD;
&#xD;
          -  LVEF between 15% and 35%&#xD;
&#xD;
          -  LVEDD ≥ 55 mm&#xD;
&#xD;
          -  Evaluable echo measurements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persistent or permanent atrial fibrillation&#xD;
&#xD;
          -  Heart surgery within the previous 3 months or planned for the time of study&#xD;
             participation; post-heart transplantation or listed for heart transplantation&#xD;
&#xD;
          -  Non-ambulatory patients&#xD;
&#xD;
          -  Chronic renal dialysis&#xD;
&#xD;
          -  Life expectancy less than 1 year due to a non-cardiac disease&#xD;
&#xD;
          -  Age &lt; 18 years and/or limited contractual capability&#xD;
&#xD;
          -  Addiction to alcohol, medical drugs or illegal drugs&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Participation in another clinical trial&#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>Peter Sogaard, MD, PhD, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Aalborg University, Aalborg University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Klaus-Jürgen Gutleben, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Herz- und Diabeteszentrum NRW, Bad Oeynhausen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aalborg Sygehus, Kardiologisk Afdeling</name>
      <address>
        <city>Aalborg</city>
        <zip>DK-9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital, Hjertemedicinsk Afdeling B</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gentofte Hospital, Department P</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital, Hjertemedicinsk Afdeling B</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Brandenburg, Immanuel Klinikum</name>
      <address>
        <city>Bernau</city>
        <zip>16321</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bielefeld Mitte</name>
      <address>
        <city>Bielefeld</city>
        <zip>33604</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus</name>
      <address>
        <city>Bielefeld</city>
        <zip>Bielefeld</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie</name>
      <address>
        <city>Mönchengladbach</city>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München - Grosshadern</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Havellandklinik Nauen</name>
      <address>
        <city>Nauen</city>
        <zip>16461</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie</name>
      <address>
        <city>Reinbek</city>
        <zip>21465</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana G. Monasterio</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology</name>
      <address>
        <city>Zwolle</city>
        <zip>8011 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>July 14, 2015</last_update_submitted>
  <last_update_submitted_qc>July 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Implantable Cardioverter-Defibrillator</keyword>
  <keyword>Intracardiac Impedance Measurement</keyword>
  <keyword>Cardiac Resynchronization Therapy</keyword>
  <keyword>Home Monitoring</keyword>
  <keyword>Reverse Remodeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT01711281
org study id: CR010
nct id: NCT01711281
lead sponsor: 
has dmc: No
Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major
      cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for
      synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters,
      physical capacity and quality of life. A continuous measurement of the left-ventricular
      volume would provide information about heart performance and could be used for both heart
      failure monitoring and optimization of CRT-therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
time frame: Month 2
description: SV will be assessed using Echo Doppler Ao-VTI (Aortic velocity time integral). SZ will be measured in parallel using intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.
measure: Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).
time frame: Month 2
description: LVESV will be assessed using echo Biplane Simpson's method. LVESZ will be measured using the intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.
measure: Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
time frame: Month 2
description: SV will be assessed using a non-invasive blood pressure measurement device. SZ will be measured using the intracardiac impedance measurement.The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.
arm group label: Intracardiac Impedance Measurement
arm group type: Experimental
intervention type: Device
intervention name: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
arm group label: Intracardiac Impedance Measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Sogaard, MD, PhD, Prof.
role: Study Chair
affiliation: Aalborg University, Aalborg University Hospital
last name: Klaus-Jürgen Gutleben, MD, PhD
role: Study Chair
affiliation: Herz- und Diabeteszentrum NRW, Bad Oeynhausen
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country: Denmark
country: Germany
country: Italy
country: Netherlands
country: Switzerland
responsible party type: Sponsor
mesh term: Heart Failure