<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/NCT03839121</url>
  </required_header>
  <id_info>
    <org_study_id>CR024</org_study_id>
    <nct_id>NCT03839121</nct_id>
  </id_info>
  <brief_title>Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm</brief_title>
  <acronym>BIO|REDUCE</acronym>
  <official_title>BIO|REDUCE: Cardiac REsynchronization Therapy With Two Ventricular Leads and Right Atrial Floating Diagnostic Dipole Installed in the Right ventricUlar Lead in Patients With CRT-D indiCation and no Sinus nodE Dysfunction</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 conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part&#xD;
      of HF patients have non-impaired sinus node function and will not be stimulated in the right&#xD;
      atrium. The implantation of the right atrial lead, which is not mandatory in these patients,&#xD;
      harbors potential complication risks and prolongs implantation procedure. The new CRT-DX&#xD;
      system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole&#xD;
      and a left ventricular lead. The aim of the BIO|REDUCE study is to assess the residual safety&#xD;
      and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with&#xD;
      an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">June 8, 2023</completion_date>
  <primary_completion_date type="Actual">June 8, 2023</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>Number of implantation of a right atrial lead after conclusion of the initial study device implantation</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of post-operative system revisions requiring an invasive re-intervention</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of lead complications requiring an invasive re-intervention</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of device or pocket infections requiring an invasive re-intervention</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Documentation of patient characteristics and medication</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of patients benefit from CRT</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Documentation of NYHA class</description>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of LVEF</measure>
    <time_frame>6 and 12 months (optional for PHD and 3 months)</time_frame>
    <description>Left ventricular ejection fraction [%]</description>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of LVESV</measure>
    <time_frame>6 and 12 months (optional for PHD and 3 months)</time_frame>
    <description>Left ventricular end-systolic volume [ml]</description>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of LVEDV</measure>
    <time_frame>6 and 12 months (optional for PHD and 3 months)</time_frame>
    <description>Left ventricular end-diastolic volume [ml]</description>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of atrial sensing amplitude</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of statistics of device pacing counters</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of programming of a non-AV-sequential pacing mode (e.g. VVI) except if justified by atrial fibrillation</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Documentation of implantation data</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
    <description>e.g. implantation time, lead position</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of serious adverse events</measure>
    <time_frame>through study completion, on average 12 months</time_frame>
    <description>Documentation of serious adverse events</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Resynchronization Therapy</condition>
  <arm_group>
    <arm_group_label>single arm: CRT-DX</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac Resynchronization Therapy (CRT)</intervention_name>
    <description>Observation and documentation of CRT patients</description>
    <arm_group_label>single arm: CRT-DX</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication according&#xD;
        to the current guidelines, who are in sinus rhythm without history of atrial fibrillation&#xD;
        (AF) and do not require right atrial (RA) lead implantation at study enrolment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is able to understand the nature of study and has provided written informed&#xD;
             consent.&#xD;
&#xD;
          -  Patient is willing and able to perform all follow up visits at the study site.&#xD;
&#xD;
          -  Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home&#xD;
             Monitoring® concept.&#xD;
&#xD;
          -  CRT-D is indicated according to the current ESC guidelines.&#xD;
&#xD;
          -  De novo implantation with no pre-existing defibrillator or pacemaker system&#xD;
&#xD;
          -  Patient is in sinus rhythm without history of atrial fibrillation.&#xD;
&#xD;
          -  Patient has no atrioventricular (AV) block I or higher (PR interval more than 200 ms).&#xD;
&#xD;
          -  Patient has no evidence of impaired sinus node function.&#xD;
&#xD;
          -  Patient has no need for atrial stimulation, has a resting heart rate (HR) &gt; 40 b.p.m&#xD;
             and achieves a peak HR ≥100 b.p.m even under intended dosage of HR lowering medication&#xD;
             verified by an appropriate method as clinical routine examination within 3 months&#xD;
             prior to enrollment&#xD;
&#xD;
          -  NYHA class II or III&#xD;
&#xD;
          -  Patient receives guideline-based optimized medical therapy for HF including heart-rate&#xD;
             lowering medication at the time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant or breast feeding.&#xD;
&#xD;
          -  Patient is less than 18 years old.&#xD;
&#xD;
          -  Patient is participating in an interventional clinical investigation.&#xD;
&#xD;
          -  Life-expectancy is less than 1 year.&#xD;
&#xD;
          -  Patient has tachycardia-bradycardia syndrome&#xD;
&#xD;
          -  Any standard contraindication for CRT-D&#xD;
&#xD;
          -  Frequent premature ventricular contractions (PVC rate &gt; 5 %/h) examined within 3&#xD;
             months prior to enrollment by appropriate routine method (e.g. 24 h holter&#xD;
             electrocardiogram)&#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 Bänsch, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>KMG Kliniken, Güstrow</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christof Kolb, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>DHM, München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kepler University Clinic</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Hradec Králové</name>
      <address>
        <city>Králová</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentralklinik Bad Berka</name>
      <address>
        <city>Bad Berka</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RHÖN-KLINIKUM Campus Bad Neustadt</name>
      <address>
        <city>Bad Neustadt An Der Saale</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charitè University Clinic, Campus Benjamin Franklin</name>
      <address>
        <city>Berlin-Steglitz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Humboldt-Klinikum</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Dresden Univesity Clinic at Technical University Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Dresden, Friedrichstadt</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelical Hospital Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich-Heine University Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Erlangen</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Würzburg</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth-Krankenhaus Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KMG Clinic Güstrow</name>
      <address>
        <city>Güstrow</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westpfalz-Klinikum</name>
      <address>
        <city>Kaiserslautern</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic SH Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic St. Georg</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DHM</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheinlandklinikum Neuss GmbH -Lukaskrankenhaus Neuss</name>
      <address>
        <city>Neuss</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marien Hospital Papenburg Aschendorf</name>
      <address>
        <city>Papenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardio Consil GmbH</name>
      <address>
        <city>Rostock</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Rothenburg ob der Tauber</name>
      <address>
        <city>Rothenburg Ob Der Tauber</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Medical University</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Diseases</keyword>
  <keyword>CRT-D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03839121
org study id: CR024
nct id: NCT03839121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part
      of HF patients have non-impaired sinus node function and will not be stimulated in the right
      atrium. The implantation of the right atrial lead, which is not mandatory in these patients,
      harbors potential complication risks and prolongs implantation procedure. The new CRT-DX
      system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole
      and a left ventricular lead. The aim of the BIO|REDUCE study is to assess the residual safety
      and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with
      an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
observational model: Cohort
time perspective: Prospective
measure: Number of implantation of a right atrial lead after conclusion of the initial study device implantation
time frame: through study completion, on average 12 months
measure: Number of post-operative system revisions requiring an invasive re-intervention
time frame: through study completion, on average 12 months
measure: Number of lead complications requiring an invasive re-intervention
time frame: through study completion, on average 12 months
measure: Number of device or pocket infections requiring an invasive re-intervention
time frame: through study completion, on average 12 months
measure: Documentation of patient characteristics and medication
time frame: through study completion, on average 12 months
measure: Assessment of patients benefit from CRT
time frame: Baseline, 3, 6 and 12 months
description: Documentation of NYHA class
measure: Documentation of LVEF
time frame: 6 and 12 months (optional for PHD and 3 months)
description: Left ventricular ejection fraction [%]
measure: Documentation of LVESV
time frame: 6 and 12 months (optional for PHD and 3 months)
description: Left ventricular end-systolic volume [ml]
measure: Documentation of LVEDV
time frame: 6 and 12 months (optional for PHD and 3 months)
description: Left ventricular end-diastolic volume [ml]
measure: Documentation of atrial sensing amplitude
time frame: through study completion, on average 12 months
measure: Documentation of statistics of device pacing counters
time frame: through study completion, on average 12 months
measure: Documentation of programming of a non-AV-sequential pacing mode (e.g. VVI) except if justified by atrial fibrillation
time frame: through study completion, on average 12 months
measure: Documentation of implantation data
time frame: through study completion, on average 12 months
description: e.g. implantation time, lead position
measure: Number of serious adverse events
time frame: through study completion, on average 12 months
description: Documentation of serious adverse events
arm group label: single arm: CRT-DX
intervention type: Device
intervention name: Cardiac Resynchronization Therapy (CRT)
description: Observation and documentation of CRT patients
arm group label: single arm: CRT-DX
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dietmar Bänsch, Prof.
role: Principal Investigator
affiliation: KMG Kliniken, Güstrow
last name: Christof Kolb, Prof.
role: Principal Investigator
affiliation: DHM, München
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Czechia
country: Germany
country: Hungary
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided