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

Boston Children's Hospital

Status: Completed

Conditions: Supraventricular Tachycardia

Treatments: Device: Intracardiac echocardiography and 3D navigational system

Study type: Interventional

Funder types: Other

Identifiers

NCT00979303

08110505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Control Group

No Intervention group

Description:

Control Patients - Undergo ablation procedures with radiation/fluoroscopy only

Study Group

Experimental group

Description:

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

Treatment:

Device: Intracardiac echocardiography and 3D navigational system