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

Supraventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979303
• Other study ID #: 08110505
• Status: Completed
• Phase: N/A
• First received: September 17, 2009
• Last updated: February 8, 2018
• Start date: January 9, 2009
• Est. completion date: May 28, 2010

Study information

• Verified date: February 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 28, 2010
• Est. primary completion date: September 28, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Device:
• Intracardiac echocardiography and 3D navigational system
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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miyake CY, Mah DY, Atallah J, Oikle HP, Melgar ML, Alexander ME, Berul CI, Cecchin F, Walsh EP, Triedman JK. Nonfluoroscopic imaging systems reduce radiation exposure in children undergoing ablation of supraventricular tachycardia. Heart Rhythm. 2011 Apr; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Fluoroscopy Time	Total fluoroscopy time in minutes	During the Ablation procedure
Secondary	Total Radiation Exposure	Total radiation exposure measured in mGy	During Ablation Procedure