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

Not Applicable

• Conditions: Ventricular Premature Complexes; Ventricular Tachycardia; Ventricular Arrythmia
• Interventions: Procedure: Zero-fluoroscopy ablation; Procedure: Conventional fluoroscopy ablation

• Registration Number: NCT03041519
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-10
• Status Verified: 2017-01
• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02
• Primary Completion: 2017-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zero-fluoroscopy ablation	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.
Conventional fluoroscopy ablation	Conventional fluoroscopy ablation	Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure.

Primary Outcome Measures

Name	Time	Method
Procedural success rates	3 months

Secondary Outcome Measures

Name	Time	Method
Complications	1 year
Immediate success rate	10~30minutes
Total procedure time	during procedure
Fluoroscopy time	during procedure

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China