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

February 8, 2018 updated by: Christina Yumi Miyake, Boston Children's Hospital

The Adjunct Use of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
EXPERIMENTAL: Study Group
Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.
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.
Other Names:
  • AcuNav Intracardiac Echocardiography
  • NavX 3D navigational system
  • CARTO 3D navigational system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Christina Y. Miyake, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 9, 2009

Primary Completion (ACTUAL)

September 28, 2009

Study Completion (ACTUAL)

May 28, 2010

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (ESTIMATE)

September 18, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08110505

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Archived consent, protocol and analytic plan.
    Information comments: Study completed prior to change in common rule. Requests should be directed to the investigation team at Boston Children's Hospital through mark.alexander@cardio.chboston.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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