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

• Sponsor: Tongji Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03041519
• Collaborator: Fu Wai Hospital, Beijing, China (Other), Xinyang Central Hospital (Other), Ningbo No. 1 Hospital (Other), Shanghai Tongji Hospital, Tongji University School of Medicine (Other), Guangxi Medical University (Other)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 86
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Arrythmia; Ventricular Premature Complexes; Ventricular Tachycardia	Procedure: Zero-fluoroscopy ablation; Procedure: Conventional fluoroscopy ablation	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Procedural success rates [3 months]

Secondary Outcome Measures

1. Total procedure time [during procedure]

2. Fluoroscopy time [during procedure]

3. Complications [1 year]

4. Immediate success rate [10~30minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ventricular Tachycardia

• Ventricular Premature Complexes

Exclusion Criteria:

• Organic ventricular tachycardia or ventricular premature complexes

• Drug-induced ventricular tachycardia or ventricular premature complexes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital	Wuhan	Hubei	China	430030

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

• Principal Investigator: Yan Wang, PhD, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

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. Review.
• 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. Review.
• Koźluk E, Gawrysiak M, Piątkowska A, Lodziński P, Kiliszek M, Małkowska S, Zaczek R, Piątkowski R, Opolski G, Kozłowski 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.

• Responsible Party: Yan Wang, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03041519
• Other Study ID Numbers: TJHXXG-ZF-VT-20161220
• First Posted: Feb 2, 2017
• Last Update Posted: Feb 2, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yan Wang, Professor, Tongji Hospital: Fluoroscopy; Ablation; Three dimensional; Ventricular arrhythmias; Radiation
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes

Study Results

No Results Posted as of Feb 2, 2017