<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/NCT03042078</url>
  </required_header>
  <id_info>
    <org_study_id>TJHCDD-ZF-PSVT-20140301</org_study_id>
    <nct_id>NCT03042078</nct_id>
  </id_info>
  <brief_title>Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia</brief_title>
  <acronym>ZFA-PSVT</acronym>
  <official_title>Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangyang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Morristown Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo No. 1 Hospital</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 aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic&#xD;
      approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus&#xD;
      fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac&#xD;
      arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the&#xD;
      operation staffs. Recently,three-dimensional navigation systems have been developed and&#xD;
      implemented in electrophysiological procedures for guiding catheters inside the heart&#xD;
      chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system&#xD;
      used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal&#xD;
      supraventricular tachycardia. This study is aimed to compare the feasibility, safety and&#xD;
      efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic&#xD;
      approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular&#xD;
      tachycardia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 rate</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immediate success rate</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence Rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Paroxysmal Supraventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>Zero-fluoroscopic ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional fluoroscopic ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zero-fluoroscopic ablation</intervention_name>
    <description>Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.</description>
    <arm_group_label>Zero-fluoroscopic ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional fluoroscopic ablation</intervention_name>
    <description>Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.</description>
    <arm_group_label>Conventional fluoroscopic ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Atrioventricular Nodal Reentrant Tachycardia&#xD;
&#xD;
          -  Atrioventricular Reentrant Tachycardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial Tachycardia&#xD;
&#xD;
          -  Organic supraventricular tachycardia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 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 Wuhan, Hubei China</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>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>Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015.</citation>
    <PMID>26034742</PMID>
  </reference>
  <reference>
    <citation>Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10.</citation>
    <PMID>23750689</PMID>
  </reference>
  <reference>
    <citation>Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312.</citation>
    <PMID>22875320</PMID>
  </reference>
  <reference>
    <citation>Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16. Erratum In: J Vasc Surg. 2012 Feb;55(2):627.</citation>
    <PMID>20843630</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 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>Paroxysmal supraventricular tachycardia</keyword>
  <keyword>Radiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Supraventricular</mesh_term>
    <mesh_term>Tachycardia, Ventricular</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/NCT03042078
org study id: TJHCDD-ZF-PSVT-20140301
nct id: NCT03042078
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic
      approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus
      fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac
      arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the
      operation staffs. Recently,three-dimensional navigation systems have been developed and
      implemented in electrophysiological procedures for guiding catheters inside the heart
      chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system
      used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal
      supraventricular tachycardia. This study is aimed to compare the feasibility, safety and
      efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic
      approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular
      tachycardia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Procedural success rate
time frame: one year
measure: Complications
time frame: one year
measure: Immediate success rate
time frame: one day
measure: Recurrence Rate
time frame: 1 year
measure: Total procedure time
time frame: one day
measure: Fluoroscopy time
time frame: one day
arm group label: Zero-fluoroscopic ablation
arm group type: Experimental
description: Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.
arm group label: Conventional fluoroscopic ablation
arm group type: Active Comparator
description: Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.
intervention type: Device
intervention name: Zero-fluoroscopic ablation
description: Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
arm group label: Zero-fluoroscopic ablation
intervention type: Device
intervention name: Conventional fluoroscopic ablation
description: Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.
arm group label: Conventional fluoroscopic ablation
criteria: 
gender: All
minimum age: 12 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yan Wang, PhD
role: Principal Investigator
affiliation: Tongji Hospital Wuhan, Hubei China
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: 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: Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015.
PMID: 26034742
citation: Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10.
PMID: 23750689
citation: Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312.
PMID: 22875320
citation: Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16. Erratum In: J Vasc Surg. 2012 Feb;55(2):627.
PMID: 20843630
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Yan Wang
investigator title: Professor
mesh term: Tachycardia
mesh term: Tachycardia, Supraventricular
mesh term: Tachycardia, Ventricular
sharing ipd: No