<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/NCT02247427</url>
  </required_header>
  <id_info>
    <org_study_id>TYIH-132</org_study_id>
    <nct_id>NCT02247427</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders</brief_title>
  <official_title>Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuksek Ihtisas Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuksek Ihtisas Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine clinical outcomes related to deactivation of&#xD;
      Cardiac Resynchronization Therapy device in subjects with super response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical/Echocardiographic outcome</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants experiencing mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants experiencing heart failure hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Resynchronization Therapy Device intervention</measure>
    <time_frame>12 months</time_frame>
    <description>Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Off-pace group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Deactivated device group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>On-Pace group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Ongoing device activity group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac Resynchronization Therapy Device</intervention_name>
    <description>Cardiac Resynchronization Therapy Device pacing activity, on or off</description>
    <arm_group_label>Off-pace group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  super response to Cardiac Resynchronization Therapy&#xD;
&#xD;
          -  near normal Left ventricular ejection fraction&#xD;
&#xD;
          -  &gt;99% pacing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;99% pacing&#xD;
&#xD;
          -  atrial fibrillation&#xD;
&#xD;
          -  ischemic cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serkan Cay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yuksek Ihtisas Hospital</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuksek Ihtisas Hospital</investigator_affiliation>
    <investigator_full_name>Serkan Cay</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Heart failure</keyword>
  <keyword>Super responder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 22, 2015</submitted>
    <returned>March 5, 2015</returned>
  </pending_results>
  <!-- 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/NCT02247427
org study id: TYIH-132
nct id: NCT02247427
lead sponsor: 
has dmc: No
The purpose of this study is to determine clinical outcomes related to deactivation of
      Cardiac Resynchronization Therapy device in subjects with super response.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Clinical/Echocardiographic outcome
time frame: 12 months
description: Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter.
measure: Mortality
time frame: 12 months
description: Number of participants experiencing mortality
measure: Heart failure hospitalization
time frame: 12 months
description: Number of participants experiencing heart failure hospitalization
measure: Cardiac Resynchronization Therapy Device intervention
time frame: 12 months
description: Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes.
arm group label: Off-pace group
arm group type: Experimental
description: Deactivated device group
arm group label: On-Pace group
arm group type: No Intervention
description: Ongoing device activity group
intervention type: Device
intervention name: Cardiac Resynchronization Therapy Device
description: Cardiac Resynchronization Therapy Device pacing activity, on or off
arm group label: Off-pace group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Serkan Cay, MD
role: Principal Investigator
affiliation: Yuksek Ihtisas Hospital
responsible party type: Principal Investigator
investigator affiliation: Yuksek Ihtisas Hospital
investigator full name: Serkan Cay
investigator title: Associate Professor
mesh term: Cardiomyopathies
submitted: February 22, 2015
returned: March 5, 2015