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

Primary Purpose

Ventricular Arrythmia, Ventricular Premature Complexes, Ventricular Tachycardia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zero-fluoroscopy ablation
Conventional fluoroscopy ablation
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Arrythmia focused on measuring Fluoroscopy, Ablation, Three dimensional, Ventricular arrhythmias, Radiation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ventricular Tachycardia
  • Ventricular Premature Complexes

Exclusion Criteria:

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

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero-fluoroscopy ablation

Conventional fluoroscopy ablation

Arm 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.

Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.

Outcomes

Primary Outcome Measures

Procedural success rates

Secondary Outcome Measures

Total procedure time
Fluoroscopy time
Complications
Immediate success rate

Full Information

First Posted
January 29, 2017
Last Updated
January 31, 2017
Sponsor
Tongji Hospital
Collaborators
Fu Wai Hospital, Beijing, China, Xinyang Central Hospital, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03041519
Brief Title
Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias
Acronym
ZFOVA
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
Fu Wai Hospital, Beijing, China, Xinyang Central Hospital, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Guangxi Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia, Ventricular Premature Complexes, Ventricular Tachycardia
Keywords
Fluoroscopy, Ablation, Three dimensional, Ventricular arrhythmias, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zero-fluoroscopy ablation
Arm Type
Experimental
Arm 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 Title
Conventional fluoroscopy ablation
Arm Type
Active Comparator
Arm 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(s)
Zero-fluoroscopy ablation
Intervention Description
Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
Intervention Type
Procedure
Intervention Name(s)
Conventional fluoroscopy ablation
Intervention Description
Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.
Primary Outcome Measure Information:
Title
Procedural success rates
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Total procedure time
Time Frame
during procedure
Title
Fluoroscopy time
Time Frame
during procedure
Title
Complications
Time Frame
1 year
Title
Immediate success rate
Time Frame
10~30minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, PhD
Phone
86-27-83663280
Email
newswangyan@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guangzhi Chen, PhD
Phone
86-27-83662842
Email
chengz2003@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD
Phone
+86-13697326307
Email
newswangyan@126.com
First Name & Middle Initial & Last Name & Degree
Guangzhi Chen, PhD
Phone
86-27-83662842
Email
chengz2003@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25432138
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.
Results Reference
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PubMed Identifier
22526222
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.
Results Reference
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PubMed Identifier
24273563
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.
Results Reference
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Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias

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