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

Primary Purpose

Supraventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intracardiac echocardiography and 3D navigational system
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraventricular Tachycardia focused on measuring Pediatric, Electrophysiology, Ablation, Radiation, Devices, SVT

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Study Group

Arm Description

Control Patients - Undergo ablation procedures with radiation/fluoroscopy only

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

Outcomes

Primary Outcome Measures

Total Fluoroscopy Time
Total fluoroscopy time in minutes

Secondary Outcome Measures

Total Radiation Exposure
Total radiation exposure measured in mGy

Full Information

First Posted
September 17, 2009
Last Updated
February 8, 2018
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00979303
Brief Title
Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
Official Title
The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 9, 2009 (Actual)
Primary Completion Date
September 28, 2009 (Actual)
Study Completion Date
May 28, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia
Keywords
Pediatric, Electrophysiology, Ablation, Radiation, Devices, SVT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.
Intervention Type
Device
Intervention Name(s)
Intracardiac echocardiography and 3D navigational system
Other Intervention Name(s)
AcuNav Intracardiac Echocardiography, NavX 3D navigational system, CARTO 3D navigational system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Fluoroscopy Time
Description
Total fluoroscopy time in minutes
Time Frame
During the Ablation procedure
Secondary Outcome Measure Information:
Title
Total Radiation Exposure
Description
Total radiation exposure measured in mGy
Time Frame
During Ablation Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Y. Miyake, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21167315
Citation
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;8(4):519-25. doi: 10.1016/j.hrthm.2010.12.022. Epub 2010 Dec 15.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Archived consent, protocol and analytic plan.
Available IPD/Information URL
http://www.childrenshospital.org/
Available IPD/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

Learn more about this trial

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

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