<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/NCT01694550</url>
  </required_header>
  <id_info>
    <org_study_id>OVGU-Kar-011</org_study_id>
    <nct_id>NCT01694550</nct_id>
  </id_info>
  <brief_title>QT Interval in Patients With Pacemaker Dependency</brief_title>
  <acronym>QT-TENDENCY</acronym>
  <official_title>Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Magdeburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Magdeburg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine a correction term for an adapted QT interval during&#xD;
      ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting&#xD;
      for the QT intervals in various pacing conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation aims at determining a possibility to assess the usefulness of various&#xD;
      formulae that correct for the different effects of various pacing modes on the QT interval.&#xD;
      More specifically, the hypothesis will be tested that applying adequate correction will&#xD;
      preserve the predictive power of the QT-interval regarding proarrhythmia in various cardiac&#xD;
      pathologies and therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Corrected QT Interval in Patients With Pacemaker Dependency</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>High Degree AV-block</condition>
  <condition>Left Bundle Branch Block</condition>
  <arm_group>
    <arm_group_label>Pacemaker mode programming</arm_group_label>
    <description>High grade AV-block</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      No biospecimen are necessary for the study and this issue is irrelevant.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will enroll 180 patients after an implantation of cardioverter/defibrillator or&#xD;
        pacemaker based on a standard guideline indication. The point of enrolment for all patients&#xD;
        is the time at which the patient signs and dates the ICF during the hospital stay in the&#xD;
        context of implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caucasian race&#xD;
&#xD;
          -  implanted cardioverter/defibrillator or pacemaker&#xD;
&#xD;
          -  negative pregnancy test for women of child bearing potential&#xD;
&#xD;
          -  stable function of the implanted device&#xD;
&#xD;
          -  stable medical therapy relating to the underlying disease&#xD;
&#xD;
          -  stable medical therapy of antiarrhythmic drugs and other QT-time changing drugs&#xD;
&#xD;
          -  no instability of rhythm&#xD;
&#xD;
          -  x-ray of thorax during device implantation in two levels (ap and ll axis)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coronary heart disease and angina pectoris symptoms&#xD;
&#xD;
          -  patient with acute myocardial infarction or CABG while the last 4 weeks&#xD;
&#xD;
          -  patient with tachycardia and a rest frequency &gt;80 bpm&#xD;
&#xD;
          -  patient with severe pulmonary disease&#xD;
&#xD;
          -  patient with anaemia&#xD;
&#xD;
          -  patient with acute infections&#xD;
&#xD;
          -  patient with severe kidney or liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir Said, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Magdeburg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>October 27, 2016</last_update_submitted>
  <last_update_submitted_qc>October 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Magdeburg</investigator_affiliation>
    <investigator_full_name>Dr. Samir Said</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>pacemaker</keyword>
  <keyword>ICD / CRTD</keyword>
  <keyword>corrected QT-interval</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bundle-Branch Block</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/NCT01694550
org study id: OVGU-Kar-011
nct id: NCT01694550
lead sponsor: 
has dmc: Yes
The aim of this study is to examine a correction term for an adapted QT interval during
      ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting
      for the QT intervals in various pacing conditions.
This investigation aims at determining a possibility to assess the usefulness of various
      formulae that correct for the different effects of various pacing modes on the QT interval.
      More specifically, the hypothesis will be tested that applying adequate correction will
      preserve the predictive power of the QT-interval regarding proarrhythmia in various cardiac
      pathologies and therapies.
observational model: Cohort
time perspective: Prospective
measure: Corrected QT Interval in Patients With Pacemaker Dependency
time frame: baseline
arm group label: Pacemaker mode programming
description: High grade AV-block
No biospecimen are necessary for the study and this issue is irrelevant.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Samir Said, Dr.
role: Principal Investigator
affiliation: Magdeburg University
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Magdeburg
investigator full name: Dr. Samir Said
investigator title: Dr. med.
mesh term: Bundle-Branch Block