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

Not Applicable

Completed

• Conditions: Supraventricular Tachycardia
• Interventions: Device: Intracardiac echocardiography and 3D navigational system

• Registration Number: NCT00979303
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2009-09-28
• Study Completion: 2010-05-28
• Results First Submitted: 2017-11-10
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-08
• Last Update Submitted: 2018-02-08
• Results First Posted: 2018-03-08
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Intracardiac echocardiography and 3D navigational system	Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.

Primary Outcome Measures

Name	Time	Method
Total Fluoroscopy Time	During the Ablation procedure	Total fluoroscopy time in minutes

Secondary Outcome Measures

Name	Time	Method
Total Radiation Exposure	During Ablation Procedure	Total radiation exposure measured in mGy

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States