Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

Study Overview
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Brief Summary
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This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Detailed Description
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Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Official Title
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Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

Conditions
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Paroxysmal Supraventricular Tachycardia

Intervention / Treatment
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* Device: Zero-fluoroscopic ablation
* Device: Conventional fluoroscopic ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Atrioventricular Nodal Reentrant Tachycardia Atrioventricular Reentrant Tachycardia Exclusion Criteria: Atrial Tachycardia Organic supraventricular tachycardia

Ages Eligible for Study
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Minimum Age: 12 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero-fluoroscopic ablation<br>Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy. | Device: Zero-fluoroscopic ablation<br>* Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.<br>|
| Active Comparator: Conventional fluoroscopic ablation<br>Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy. | Device: Conventional fluoroscopic ablation<br>* Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate | Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications were defined as pseudoaneurysm, arterialvenous fistula, pneumothorax, second- or third-degree atrioventricular block, cardiac tamponade, or other serious complications requiring intervention. | one year | 
| Immediate success rate | Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine. | one day | 
| Recurrence Rate | 2. An ECG and electrophysiology study would be performed to rule out recurrence when the patients had suspicious symptoms or signs. | 1 year | 
| Total procedure time | Procedure time (in minutes) was defined as the interval from the beginning of local anesthesia to extraction of all femoral venous sheaths at the end of the procedure. Total ablation time was calculated in seconds but time for tentative ablation was not taken into account. | one day | 
| Fluoroscopy time | 2. Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure. | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluoroscopy, Ablation, Three dimensional, Paroxysmal supraventricular tachycardia, Radiation