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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Children's Hospital Boston. Recruitment status was Recruiting

First Received on September 17, 2009. No Changes Posted

Sponsor:	Children's Hospital Boston
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00979303

Purpose

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.

Condition	Intervention	Phase
Supraventricular Tachycardia	Device: Intracardiac echocardiography and 3D navigational system	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Total fluoroscopy time [ Time Frame: During the Ablation procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total Radiation Exposure [ Time Frame: During Ablation Procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	January 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
Experimental: 2 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

Eligibility

Ages Eligible for Study:	8 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979303

Contacts

Contact: Christina Y. Miyake, MD	617-355-6432	christina.miyake@cardio.chboston.org
Contact: John K. Triedman, MD	617-355-6432	john.triedman@cardio.chboston.org

Locations

United States, Massachusetts
Children's Hospital Boston	Recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: John K. Triedman, MD
Sub-Investigator: Frank Cecchin, MD
Sub-Investigator: Charles I. Berul, MD
Sub-Investigator: Mark Alexander, MD
Sub-Investigator: Ed P Walsh, MD
Sub-Investigator: Joseph Atallah, MD
Sub-Investigator: Doug Mah, MD
Sub-Investigator: Heath Oikle

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:

Christina Y. Miyake, MD

Children's Hospital Boston

More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Dec 15.

Responsible Party:	Christina Miyake, MD Principal Investigator, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00979303 History of Changes
Other Study ID Numbers:	08110505
Study First Received:	September 17, 2009
Last Updated:	September 17, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

Pediatric
Electrophysiology
Ablation

Radiation
Devices
SVT

Additional relevant MeSH terms:

Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012