<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/NCT03041519</url>
  </required_header>
  <id_info>
    <org_study_id>TJHXXG-ZF-VT-20161220</org_study_id>
    <nct_id>NCT03041519</nct_id>
  </id_info>
  <brief_title>Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias</brief_title>
  <acronym>ZFOVA</acronym>
  <official_title>Multi-center, Randomized, Controlled, Prospective Trial to Compare the Feasibility, Safety, and Efficacy of Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fu Wai Hospital, Beijing, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinyang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo No. 1 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy&#xD;
      approach using Ensite NavX as the only imaging modality with conventional fluoroscopic&#xD;
      approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional&#xD;
      fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheter ablation is a well-established treatment to treat patients with a wide range of&#xD;
      heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation&#xD;
      of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure&#xD;
      to both the patients and operation staffs; three-dimensional mapping systems, including CARTO&#xD;
      and Ensite NavX, have been developed and implemented in electrophysiological procedure for&#xD;
      the navigation of catheters inside the heart chambers. Ensite NavX system can be used for&#xD;
      zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to&#xD;
      compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX&#xD;
      as the only imaging modality with conventional fluoroscopic approach for the catheter&#xD;
      ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use&#xD;
      fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural success rates</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate success rate</measure>
    <time_frame>10~30minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Ventricular Arrythmia</condition>
  <condition>Ventricular Premature Complexes</condition>
  <condition>Ventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>Zero-fluoroscopy ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional fluoroscopy ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Zero-fluoroscopy ablation</intervention_name>
    <description>Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.</description>
    <arm_group_label>Zero-fluoroscopy ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional fluoroscopy ablation</intervention_name>
    <description>Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.</description>
    <arm_group_label>Conventional fluoroscopy ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ventricular Tachycardia&#xD;
&#xD;
          -  Ventricular Premature Complexes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organic ventricular tachycardia or ventricular premature complexes&#xD;
&#xD;
          -  Drug-induced ventricular tachycardia or ventricular premature complexes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Wang, PhD</last_name>
    <phone>86-27-83663280</phone>
    <email>newswangyan@tjh.tjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guangzhi Chen, PhD</last_name>
    <phone>86-27-83662842</phone>
    <email>chengz2003@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Wang, PhD</last_name>
      <phone>+86-13697326307</phone>
      <email>newswangyan@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Guangzhi Chen, PhD</last_name>
      <phone>86-27-83662842</phone>
      <email>chengz2003@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24.</citation>
    <PMID>25432138</PMID>
  </reference>
  <reference>
    <citation>Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555.</citation>
    <PMID>22526222</PMID>
  </reference>
  <reference>
    <citation>Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5.</citation>
    <PMID>24273563</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Yan Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Fluoroscopy</keyword>
  <keyword>Ablation</keyword>
  <keyword>Three dimensional</keyword>
  <keyword>Ventricular arrhythmias</keyword>
  <keyword>Radiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Ventricular Premature Complexes</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/NCT03041519
org study id: TJHXXG-ZF-VT-20161220
nct id: NCT03041519
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy
      approach using Ensite NavX as the only imaging modality with conventional fluoroscopic
      approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional
      fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
Catheter ablation is a well-established treatment to treat patients with a wide range of
      heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation
      of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure
      to both the patients and operation staffs; three-dimensional mapping systems, including CARTO
      and Ensite NavX, have been developed and implemented in electrophysiological procedure for
      the navigation of catheters inside the heart chambers. Ensite NavX system can be used for
      zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to
      compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX
      as the only imaging modality with conventional fluoroscopic approach for the catheter
      ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use
      fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Procedural success rates
time frame: 3 months
measure: Total procedure time
time frame: during procedure
measure: Fluoroscopy time
time frame: during procedure
measure: Complications
time frame: 1 year
measure: Immediate success rate
time frame: 10~30minutes
arm group label: Zero-fluoroscopy ablation
arm group type: Experimental
description: Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure.
arm group label: Conventional fluoroscopy ablation
arm group type: Active Comparator
description: Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.
intervention type: Procedure
intervention name: Zero-fluoroscopy ablation
description: Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
arm group label: Zero-fluoroscopy ablation
intervention type: Procedure
intervention name: Conventional fluoroscopy ablation
description: Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.
arm group label: Conventional fluoroscopy ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yan Wang, PhD
role: Principal Investigator
affiliation: Tongji Hospital
last name: Yan Wang, PhD
phone: 86-27-83663280
email: newswangyan@tjh.tjmu.edu.cn
last name: Guangzhi Chen, PhD
phone: 86-27-83662842
email: chengz2003@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24.
PMID: 25432138
citation: Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555.
PMID: 22526222
citation: Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5.
PMID: 24273563
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Yan Wang
investigator title: Professor
mesh term: Arrhythmias, Cardiac
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Ventricular Premature Complexes
sharing ipd: No