Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.

Detailed Description
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The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.

Official Title
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The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia

Conditions
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Supraventricular Tachycardia

Intervention / Treatment
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* Device: Intracardiac echocardiography and 3D navigational system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/=8 Weight >/=25kg Structurally normal heart (no major cardiac defects) History of SVT No prior history of cardiac surgery or ablation Exclusion Criteria: Congenital Heart Disease Prior history of cardiac surgery or ablation

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 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
Interventional Model Description: Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Control Patients - Undergo ablation procedures with radiation/fluoroscopy only | |
| Experimental: Study Group<br>Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation. | Device: Intracardiac echocardiography and 3D navigational system<br>* Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.<br>* Other names: CARTO 3D navigational system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Fluoroscopy Time | Total fluoroscopy time in minutes | During the Ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Radiation Exposure | Total radiation exposure measured in mGy | During Ablation Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Electrophysiology, Ablation, Radiation, Devices, SVT