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Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias (ZFOVA)

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ClinicalTrials.gov Identifier: NCT03041519
Recruitment Status : Unknown
Verified January 2017 by Yan Wang, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
Fu Wai Hospital, Beijing, China
Xinyang Central Hospital
Ningbo No. 1 Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Guangxi Medical University
Information provided by (Responsible Party):
Yan Wang, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE January 29, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
Procedural success rates [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Total procedure time [ Time Frame: during procedure ]
  • Fluoroscopy time [ Time Frame: during procedure ]
  • Complications [ Time Frame: 1 year ]
  • Immediate success rate [ Time Frame: 10~30minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Ventricular Arrythmia
  • Ventricular Premature Complexes
  • Ventricular Tachycardia
Intervention  ICMJE
  • Procedure: Zero-fluoroscopy ablation
    Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
  • Procedure: Conventional fluoroscopy ablation
    Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.
Study Arms  ICMJE
  • Experimental: Zero-fluoroscopy ablation
    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.
    Intervention: Procedure: Zero-fluoroscopy ablation
  • Active Comparator: Conventional fluoroscopy ablation
    Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.
    Intervention: Procedure: Conventional fluoroscopy ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ventricular Tachycardia
  • Ventricular Premature Complexes

Exclusion Criteria:

  • Organic ventricular tachycardia or ventricular premature complexes
  • Drug-induced ventricular tachycardia or ventricular premature complexes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041519
Other Study ID Numbers  ICMJE TJHXXG-ZF-VT-20161220
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yan Wang, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE
  • Fu Wai Hospital, Beijing, China
  • Xinyang Central Hospital
  • Ningbo No. 1 Hospital
  • Shanghai Tongji Hospital, Tongji University School of Medicine
  • Guangxi Medical University
Investigators  ICMJE
Principal Investigator: Yan Wang, PhD Tongji Hospital
PRS Account Tongji Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP