<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/NCT03249545</url>
  </required_header>
  <id_info>
    <org_study_id>ozcan02</org_study_id>
    <nct_id>NCT03249545</nct_id>
  </id_info>
  <brief_title>Late Effect of Ablation on Premature Ventricular Complex Ablation</brief_title>
  <official_title>Late Effect of Ablation on Premature Ventricular Complex 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>
      Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally&#xD;
      acutely abolition of PVC at the time of ablation accepted as successful ablation. However in&#xD;
      some patients this effect occurs lately. In this study investigators sought late effect of&#xD;
      ablation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On tissue level ablation lesion deepens and enlarges by time following the procedure. Based&#xD;
      on this, investigators aimed to seek patients who has no acute success but late success. This&#xD;
      phenomenon occurs in some patients. Investigators investigate the characteristics of those&#xD;
      patients on both procedural and clinical aspects. Investigators enroll patients applied&#xD;
      during prespecified dates&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Success</measure>
    <time_frame>3 months</time_frame>
    <description>Continuation of ablation on the long term</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Premature Ventricular Complex</condition>
  <condition>Electrophysiology</condition>
  <condition>Ablation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals having premature complexes and matching ablation indications are included and&#xD;
        selection will be based on above mentioned criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who had both of the criteria below&#xD;
&#xD;
          -  Presence of premature ventricular complex requiring ablation&#xD;
&#xD;
          -  Successfully abolition of premature ventricular complex hours after the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who had either of below mentioned criteria&#xD;
&#xD;
          -  Abolition of premature ventricular complex during the procedure&#xD;
&#xD;
          -  Unsuccessful 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_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 R 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 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 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>MD,Associate Profesor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Ventricular Premature Complexes</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/NCT03249545
org study id: ozcan02
nct id: NCT03249545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally
      acutely abolition of PVC at the time of ablation accepted as successful ablation. However in
      some patients this effect occurs lately. In this study investigators sought late effect of
      ablation
On tissue level ablation lesion deepens and enlarges by time following the procedure. Based
      on this, investigators aimed to seek patients who has no acute success but late success. This
      phenomenon occurs in some patients. Investigators investigate the characteristics of those
      patients on both procedural and clinical aspects. Investigators enroll patients applied
      during prespecified dates
observational model: Cohort
time perspective: Prospective
measure: Success
time frame: 3 months
description: Continuation of ablation on the long term
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, 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: MD,Associate Profesor
mesh term: Premature Birth
mesh term: Ventricular Premature Complexes