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OpenTrials
Completed

NCT Number: NCT00979303

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

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.

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Key information

Conditions

Supraventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Supraventricular

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracardiac echocardiography and 3D navigational system

Device

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.

Other names: AcuNav Intracardiac Echocardiography, NavX 3D navigational system, CARTO 3D navigational system

Primary outcomes

  1. Total Fluoroscopy Time

    Time frame: During the Ablation procedure

    Total fluoroscopy time in minutes

Secondary outcomes

  1. Total Radiation Exposure

    Time frame: During Ablation Procedure

    Total radiation exposure measured in mGy

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Sep 18, 2009
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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