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

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.

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 Overview

• Status: Unknown
• Conditions: Ventricular Tachycardia; Ventricular Arrythmia; Ventricular Premature Complexes
• Intervention / Treatment: Procedure: Zero-fluoroscopy ablation; Procedure: Conventional fluoroscopy ablation

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: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Guangzhi Chen, PhD; Phone Number: 86-27-83662842; Email: chengz2003@163.com
      • Contact: Yan Wang, PhD; Phone Number: +86-13697326307; Email: newswangyan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ventricular Tachycardia
• Ventricular Premature Complexes

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Procedural success rates	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total procedure time	during procedure
Fluoroscopy time	during procedure
Complications	1 year
Immediate success rate	10~30minutes

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Guangxi Medical University; Fu Wai Hospital, Beijing, China; Ningbo No. 1 Hospital; Shanghai Tongji Hospital, Tongji University School of Medicine; Xinyang Central Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (ESTIMATE): February 2, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Ablation; Radiation; Ventricular arrhythmias; Fluoroscopy; Three dimensional
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: TJHXXG-ZF-VT-20161220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO