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

Ventricular Tachycardia Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03041519
• Other study ID #: TJHXXG-ZF-VT-20161220
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2017
• Last updated: January 31, 2017
• Start date: October 2011
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Tongji Hospital
• Contact: Yan Wang, PhD
• Phone: 86-27-83663280
• Email: newswangyan[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Ventricular Tachycardia

• Ventricular Premature Complexes

Exclusion Criteria:

• Organic ventricular tachycardia or ventricular premature complexes

• Drug-induced ventricular tachycardia or ventricular premature complexes

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

Procedure:
• Zero-fluoroscopy ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
• Conventional fluoroscopy ablation
Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (6)

Lead Sponsor	Collaborator
Tongji Hospital	Fu Wai Hospital, Beijing, China, Guangxi Medical University, Ningbo No. 1 Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Xinyang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success rates		3 months
Secondary	Total procedure time		during procedure
Secondary	Fluoroscopy time		during procedure
Secondary	Complications		1 year
Secondary	Immediate success rate		10~30minutes