<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/NCT03244748</url>
  </required_header>
  <id_info>
    <org_study_id>ozcan01</org_study_id>
    <nct_id>NCT03244748</nct_id>
  </id_info>
  <brief_title>Amiodarone Usage After Ischemic Ventricular Tachycardia Ablation</brief_title>
  <official_title>Effect of Amiodarone After Ischemic Ventricular Tachycardia Ablation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in&#xD;
      cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone&#xD;
      after ablation is needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ischemic cardiomyopathy patients have implantable cardioverter defibrillators (ICD) to&#xD;
      prevent arrhythmic deaths. Ventricular tachycardia (VT) events with frequent ICD&#xD;
      interventions in ischemic cardiomyopathy patients is encountered frequently. Frequents ICD&#xD;
      interventions is associated with worse outcomes. Anti-arrhythmic drugs ,mostly amiodarone,&#xD;
      are given prevent ventricular arrhythmias and ICD interventions that may not be curative.&#xD;
      Ablation of ventricular tachycardia is the suggested treatment when anti-drugs are without&#xD;
      effect. After ablation of ventricular arrhythmia the continuation of amiodarone is not well&#xD;
      elucidated.&#xD;
&#xD;
      In this study we aimed to enroll ischemic cardiomyopathy patients having frequent ICD&#xD;
      interventions despite medical treatment. VT ablation is performed and patients divided into&#xD;
      two groups; group one continues having amiodarone after ablation, group two does not have&#xD;
      amiodarone after ablation. Both groups will be compared in terms of recurrence and death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">March 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>six months</time_frame>
    <description>Death, ICD intervetion</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ischemic Cardiomyopathy</condition>
  <condition>Ventricular Tachycardia</condition>
  <condition>ICD Shock</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Patients underwent ablation and continued having amiodarone after the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Patients underwent ablation and not having amiodarone after the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ventricular tachycardia ablation</intervention_name>
    <description>Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We enroll ischemic heart failure patients who had frequent ventricular arrhythymias causing&#xD;
        multiple shocks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Ischemic cardiomyopathy patients applied with frequent ICD interventionor electrical storms&#xD;
        and having ejection fraction below 50%. Frequent ICD defined as more than 1 ICD&#xD;
        intervention within month. Electrical storm defined as more than 2 ICD intervention within&#xD;
        one day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with cardiomyopathies other than ischemic etiology&#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>Firat Ozcan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Firat Ozcan, Ass. Prof, MD</last_name>
    <phone>+905327854000</phone>
    <email>drfozcan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Turkiye Yuksek Ihtisas Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Firat Ozcan, Ass. Prof, MD</last_name>
      <phone>5327854000</phone>
      <email>drfozcan@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 5, 2017</last_update_submitted>
  <last_update_submitted_qc>August 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuksek Ihtisas Hospital</investigator_affiliation>
    <investigator_full_name>Fırat Özcan</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03244748
org study id: ozcan01
nct id: NCT03244748
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in
      cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone
      after ablation is needed.
Ischemic cardiomyopathy patients have implantable cardioverter defibrillators (ICD) to
      prevent arrhythmic deaths. Ventricular tachycardia (VT) events with frequent ICD
      interventions in ischemic cardiomyopathy patients is encountered frequently. Frequents ICD
      interventions is associated with worse outcomes. Anti-arrhythmic drugs ,mostly amiodarone,
      are given prevent ventricular arrhythmias and ICD interventions that may not be curative.
      Ablation of ventricular tachycardia is the suggested treatment when anti-drugs are without
      effect. After ablation of ventricular arrhythmia the continuation of amiodarone is not well
      elucidated.

      In this study we aimed to enroll ischemic cardiomyopathy patients having frequent ICD
      interventions despite medical treatment. VT ablation is performed and patients divided into
      two groups; group one continues having amiodarone after ablation, group two does not have
      amiodarone after ablation. Both groups will be compared in terms of recurrence and death.
observational model: Cohort
time perspective: Prospective
measure: Major adverse cardiovascular events
time frame: six months
description: Death, ICD intervetion
arm group label: Group 1
description: Patients underwent ablation and continued having amiodarone after the procedure
arm group label: Group 2
description: Patients underwent ablation and not having amiodarone after the procedure
intervention type: Procedure
intervention name: Ventricular tachycardia ablation
description: Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously
arm group label: Group 1
arm group label: Group 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Firat Ozcan, MD
role: Principal Investigator
affiliation: MD
last name: Firat Ozcan, Ass. Prof, MD
phone: +905327854000
email: drfozcan@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuksek Ihtisas Hospital
investigator full name: Fırat Özcan
investigator title: Associate Professor
mesh term: Cardiomyopathies
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Ischemia
sharing ipd: No