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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Ventricular Arrythmia, Ventricular Premature Complexes, Ventricular Tachycardia

Intervention / Treatment
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* Procedure: Zero-fluoroscopy ablation
* Procedure: Conventional fluoroscopy ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ventricular Tachycardia Ventricular Premature Complexes Exclusion Criteria: Organic ventricular tachycardia or ventricular premature complexes Drug-induced ventricular tachycardia or ventricular premature complexes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero-fluoroscopy ablation<br>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<br>* Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.<br>|
| Active Comparator: Conventional fluoroscopy ablation<br>Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure. | Procedure: Conventional fluoroscopy ablation<br>* Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rates |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluoroscopy, Ablation, Three dimensional, Ventricular arrhythmias, Radiation