<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/NCT01695551</url>
  </required_header>
  <id_info>
    <org_study_id>13054</org_study_id>
    <nct_id>NCT01695551</nct_id>
  </id_info>
  <brief_title>Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia</brief_title>
  <official_title>Assessment of Intracardiac and Surgace Electrogram Characteristics Correlated to Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dhanunjaya Lakkireddy, MD, FACC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the&#xD;
      lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal&#xD;
      electrical pathways located in the heart tissue. A standard procedure called a catheter&#xD;
      ablation has been used for several years to help correct these abnormal pathways and, in some&#xD;
      cases, improve or even eliminate the ventricular tachycardia.&#xD;
&#xD;
      During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate,&#xD;
      and oxygen saturation in your blood). If you choose to participate in this study we will also&#xD;
      monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain&#xD;
      during the ablation.&#xD;
&#xD;
      By doing this study, we hope to have a better understanding of patients' blood and oxygen&#xD;
      flow to their brain during an episode of Ventricular Tachycardia (VT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Identify clinical, EKG and EGM characteristics of hemodynamically unstable VT</measure>
    <time_frame>Change from Baseline to 24-48 hours after surgery</time_frame>
    <description>The investigator will be evaluating the relationship of the oxygenation level of the brain during a Ventricular Tachycardia ablation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MMSE to determine cerebral function before and after VT ablation</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>The use of the Mini-Mental Status Exam prior to the ablation will serve as a reference point and will be repeated 24 hours post exam.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Ventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>Ventricular Tachycardia</arm_group_label>
    <description>Participants in cohort will have implantable defibrillators in-situ and are undergoing ablation procedure for ventricular tachycardia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Collection Forms</intervention_name>
    <description>Participants will be asked questions relating to pre-procedure items and be asked to complete an MMSE. Subjects receive standard of care surgery. Data collected from procedures before, during and after surgery.</description>
    <arm_group_label>Ventricular Tachycardia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be selected from those that visit University of Kansas Medical Center&#xD;
        Cardiology clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Have implantable defibrillator in-situ and are undergoing ablation procedure for&#xD;
             ventricular tachycardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been hypotensive with systolic blood pressure of &lt; 80mm Hg prior to&#xD;
             procedure&#xD;
&#xD;
          -  Cerebral event as defined by Cerebrovascular Accident or Transient Ischemia Attack&#xD;
             within six months prior to procedure&#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>Dhanunjaya Lakkireddy, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Dhanunjaya Lakkireddy, MD, FACC</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Radiofrequency ablation</keyword>
  <keyword>fast heart rhythm</keyword>
  <keyword>ventricle</keyword>
  <keyword>catheter ablation</keyword>
  <keyword>ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</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/NCT01695551
org study id: 13054
nct id: NCT01695551
lead sponsor: 
has dmc: No
Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the
      lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal
      electrical pathways located in the heart tissue. A standard procedure called a catheter
      ablation has been used for several years to help correct these abnormal pathways and, in some
      cases, improve or even eliminate the ventricular tachycardia.

      During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate,
      and oxygen saturation in your blood). If you choose to participate in this study we will also
      monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain
      during the ablation.

      By doing this study, we hope to have a better understanding of patients' blood and oxygen
      flow to their brain during an episode of Ventricular Tachycardia (VT).
observational model: Cohort
time perspective: Prospective
measure: Identify clinical, EKG and EGM characteristics of hemodynamically unstable VT
time frame: Change from Baseline to 24-48 hours after surgery
description: The investigator will be evaluating the relationship of the oxygenation level of the brain during a Ventricular Tachycardia ablation.
measure: MMSE to determine cerebral function before and after VT ablation
time frame: 24 hours after surgery
description: The use of the Mini-Mental Status Exam prior to the ablation will serve as a reference point and will be repeated 24 hours post exam.
arm group label: Ventricular Tachycardia
description: Participants in cohort will have implantable defibrillators in-situ and are undergoing ablation procedure for ventricular tachycardia.
intervention type: Other
intervention name: Data Collection Forms
description: Participants will be asked questions relating to pre-procedure items and be asked to complete an MMSE. Subjects receive standard of care surgery. Data collected from procedures before, during and after surgery.
arm group label: Ventricular Tachycardia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dhanunjaya Lakkireddy, MD, FACC
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Dhanunjaya Lakkireddy, MD, FACC
investigator title: Professor
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular