<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/NCT02250547</url>
  </required_header>
  <id_info>
    <org_study_id>RCSY01 OSCAR</org_study_id>
    <nct_id>NCT02250547</nct_id>
  </id_info>
  <brief_title>Optimization With SonR Method in the ClinicAl pRactice</brief_title>
  <acronym>OSCAR</acronym>
  <official_title>Optimization With SonR Method in the ClinicAl pRactice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LivaNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LivaNova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the percentage of patients optimized at least once every month by the SonR automatic&#xD;
      optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus&#xD;
      rhythm&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thanks to the SonR technology it is possible to adjust the optimal VV and AV delays over&#xD;
      time, in a fully automatic, time saving and operator independent way. It is possible to&#xD;
      optimize the VV and AV delays in office, during follow-up visits, but also enable the&#xD;
      automatic optimization that weekly optimize the AV and VV delays.&#xD;
&#xD;
      For the reasons mentioned above, the sponsor expects that the SonR optimization method&#xD;
      increases the number of patients optimized systematically at each follow-up The purpose of&#xD;
      this study is to evaluate the percentage of patients optimized at least once every month by&#xD;
      the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in&#xD;
      sinus rhythm.&#xD;
&#xD;
      The primary objective will be evaluated as the percentage of patients successfully optimized&#xD;
      every month until M6.&#xD;
&#xD;
      A patient is considered successfully optimized by the SonR during one month if at least one&#xD;
      Atri-Ventricular (AV) or Ventricular-Ventricular (VV) optimization is completed by the SonR&#xD;
      automatic optimization method during the month.&#xD;
&#xD;
      Patients eligible for the analysis are those with SonR automatic optimization function&#xD;
      enabled and at least 50% of the time in sinus rhythm&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in sinus rhythm</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective will be evaluated as the percentage of patients successfully optimized every month until M6.&#xD;
A patient is considered successfully optimized by the SonR during one month if at least one AV or VV optimization is completed by the SonR automatic optimization method during the month.&#xD;
Patients eligible for the analysis are those with SonR automatic optimization function enabled and at least 50% of the time in sinus rhythm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with SonR automatic optimization function enabled at each follow-up</measure>
    <time_frame>6M</time_frame>
    <description>The number of patients with automatic SonR optimization enabled over the total number of patients at: Implantation, Baseline, M6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze the evolution of optimal AV and VV delays SonR optimized over time</measure>
    <time_frame>6M</time_frame>
    <description>Compare the mean and the intra-patient AV and VV delays between consecutive follow-ups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Report system-related complications</measure>
    <time_frame>6M</time_frame>
    <description>Report system-related complications</description>
  </secondary_outcome>
  <enrollment type="Anticipated">278</enrollment>
  <condition>CRT Patients</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac resyncronisation therapy - defibrillator (CRT-D) patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient eligible for implantation or implanted for less than 6 weeks (primo-implant,&#xD;
             replacement, upgrade) with a a Paradym RF SonR CRT-D and SonRtip Atrial Lead,&#xD;
             according to current available guidelines (RF=radio frequency)&#xD;
&#xD;
          -  Patient has signed and dated informed consent (according to the laws and regulations&#xD;
             of the country in which the observation is performed)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persistent atrial arrhythmias&#xD;
&#xD;
          -  Already included in another interventional clinical study&#xD;
&#xD;
          -  Not available for routine follow-up visits&#xD;
&#xD;
          -  Inability to understand the purpose of the study&#xD;
&#xD;
          -  Under guardianship&#xD;
&#xD;
          -  Under18 years old&#xD;
&#xD;
          -  Drug addiction or abuse&#xD;
&#xD;
          -  Pregnancy&#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>Carsten W Israel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Evangelischen Krankenhaus Bielefeld - Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus Linz (AKH LINZ)</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Sud Francilien</name>
      <address>
        <city>Corbeil Essonne</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Haguenau</name>
      <address>
        <city>Haguenau</city>
        <zip>67500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Marne la Vallée</name>
      <address>
        <city>Jossigny</city>
        <zip>77600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMC du Mans - Pôle Santé Sud</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique du Bois</name>
      <address>
        <city>Lille</city>
        <zip>59003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Dupuytren</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH St Philibert</name>
      <address>
        <city>Lomme</city>
        <zip>59462</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH St Joseph et St Luc</name>
      <address>
        <city>Lyon</city>
        <zip>69365</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Beauregard</name>
      <address>
        <city>Marseille</city>
        <zip>13425</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Belford Montbéliard</name>
      <address>
        <city>Montbéliard</city>
        <zip>25209</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Victor Provo</name>
      <address>
        <city>Roubaix</city>
        <zip>59056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus</name>
      <address>
        <city>Bielefeld</city>
        <zip>33617</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAP2 - Kardiologische Praxis Papenburg</name>
      <address>
        <city>Papenburg</city>
        <zip>26871</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. S. Salvatore</name>
      <address>
        <city>L'aquila</city>
        <zip>67100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.Giovanni Bosco</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Espírito Santo, E.P.E</name>
      <address>
        <city>Evora</city>
        <zip>7000-811</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central Faro</name>
      <address>
        <city>Faro</city>
        <zip>8000-386</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 10, 2013</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 10, 2017</last_update_submitted>
  <last_update_submitted_qc>November 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02250547
org study id: RCSY01 OSCAR
nct id: NCT02250547
lead sponsor: 
has dmc: No
Evaluate the percentage of patients optimized at least once every month by the SonR automatic
      optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus
      rhythm
Thanks to the SonR technology it is possible to adjust the optimal VV and AV delays over
      time, in a fully automatic, time saving and operator independent way. It is possible to
      optimize the VV and AV delays in office, during follow-up visits, but also enable the
      automatic optimization that weekly optimize the AV and VV delays.

      For the reasons mentioned above, the sponsor expects that the SonR optimization method
      increases the number of patients optimized systematically at each follow-up The purpose of
      this study is to evaluate the percentage of patients optimized at least once every month by
      the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in
      sinus rhythm.

      The primary objective will be evaluated as the percentage of patients successfully optimized
      every month until M6.

      A patient is considered successfully optimized by the SonR during one month if at least one
      Atri-Ventricular (AV) or Ventricular-Ventricular (VV) optimization is completed by the SonR
      automatic optimization method during the month.

      Patients eligible for the analysis are those with SonR automatic optimization function
      enabled and at least 50% of the time in sinus rhythm
observational model: Other
time perspective: Prospective
measure: evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in sinus rhythm
time frame: 6 months
description: The primary objective will be evaluated as the percentage of patients successfully optimized every month until M6.
A patient is considered successfully optimized by the SonR during one month if at least one AV or VV optimization is completed by the SonR automatic optimization method during the month.
Patients eligible for the analysis are those with SonR automatic optimization function enabled and at least 50% of the time in sinus rhythm
measure: Percentage of patients with SonR automatic optimization function enabled at each follow-up
time frame: 6M
description: The number of patients with automatic SonR optimization enabled over the total number of patients at: Implantation, Baseline, M6
measure: Analyze the evolution of optimal AV and VV delays SonR optimized over time
time frame: 6M
description: Compare the mean and the intra-patient AV and VV delays between consecutive follow-ups
measure: Report system-related complications
time frame: 6M
description: Report system-related complications
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carsten W Israel
role: Principal Investigator
affiliation: Evangelischen Krankenhaus Bielefeld - Germany
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country: Austria
country: France
country: Germany
country: Italy
country: Portugal
country: Spain
responsible party type: Sponsor