Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial 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-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

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 the imaging modality routinely used for cardiac device implantation and electrophysiological procedures. Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel three-dimensional mapping systems such as Ensite NavX have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX is a promising system to guide catheters inside the cardiac chambers and vessels without the use of fluoroscopy. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

Official Title
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Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for the Ablation of Right Atrial Arrhythmias

Conditions
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Atrial Arrhythmia, Atrial Premature Complexes, Atrial 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: Atrial Tachycardia Atrial Premature Complexes Exclusion Criteria: Left Atrial Premature Complexes Left Atrial Tachycardia

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>Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy. | Procedure: Zero-fluoroscopy ablation<br>* Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.<br>|
| Active Comparator: Conventional fluoroscopy ablation<br>Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system. | Procedure: Conventional fluoroscopy ablation<br>* Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total success rates | The patients have no related arrhythias or recurrence during follow up. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure time | The patients have no related arrhythias or recurrence during follow up. | during procedure | 
| Fluoroscopy time | From skin puncture to withdrawal of all the catheters. | during procedure | 
| Complications | The patients have no related complications during follow up. | 6 months | 
| Immediate success rate | Electrophysiologic study shows success of ablation | 24 hours | 
| Recurrence rate | The patients have no related arrhythias or recurrence during follow up. | 6 months | 

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