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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

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.

Condition or disease Intervention/treatment Phase
Ventricular Arrythmia Ventricular Premature Complexes Ventricular Tachycardia Procedure: Zero-fluoroscopy ablation Procedure: Conventional fluoroscopy ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : October 2011
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.

Active Comparator: Conventional fluoroscopy ablation
Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.
Procedure: Conventional fluoroscopy ablation
Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.




Primary Outcome Measures :
  1. Procedural success rates [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: during procedure ]
  2. Fluoroscopy time [ Time Frame: during procedure ]
  3. Complications [ Time Frame: 1 year ]
  4. Immediate success rate [ Time Frame: 10~30minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ventricular Tachycardia
  • Ventricular Premature Complexes

Exclusion Criteria:

  • Organic ventricular tachycardia or ventricular premature complexes
  • Drug-induced ventricular tachycardia or ventricular premature complexes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041519


Contacts
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Contact: Yan Wang, PhD 86-27-83663280 newswangyan@tjh.tjmu.edu.cn
Contact: Guangzhi Chen, PhD 86-27-83662842 chengz2003@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Yan Wang, PhD    +86-13697326307    newswangyan@126.com   
Contact: Guangzhi Chen, PhD    86-27-83662842    chengz2003@163.com   
Sponsors and Collaborators
Tongji Hospital
Fu Wai Hospital, Beijing, China
Xinyang Central Hospital
Ningbo No. 1 Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Guangxi Medical University
Investigators
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Principal Investigator: Yan Wang, PhD Tongji Hospital

Publications:
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Responsible Party: Yan Wang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03041519     History of Changes
Other Study ID Numbers: TJHXXG-ZF-VT-20161220
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yan Wang, Tongji Hospital:
Fluoroscopy
Ablation
Three dimensional
Ventricular arrhythmias
Radiation
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Cardiac Complexes, Premature