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

NCT00979303 | Completed Results DMC

• 1 other identifier: 08110505
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraventricular Tachycardia

Keywords

Pediatric; Electrophysiology; Ablation; Radiation; Devices; SVT

Outcome Measures

Primary Outcomes (1)

• Total Fluoroscopy Time

  Total fluoroscopy time in minutes

  During the Ablation procedure

Secondary Outcomes (1)

• Total Radiation Exposure

  During Ablation Procedure

Study Arms (2)

Control Group

NO INTERVENTION

Control Patients - Undergo ablation procedures with radiation/fluoroscopy only

Study Group

EXPERIMENTAL

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

Device: Intracardiac echocardiography and 3D navigational system

Interventions

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.

Also known as: AcuNav Intracardiac Echocardiography, NavX 3D navigational system, CARTO 3D navigational system

Study Group

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \>/=8
• Weight \>/=25kg
• Structurally normal heart (no major cardiac defects)
• History of SVT
• No prior history of cardiac surgery or ablation

You may not qualify if:

• Congenital Heart Disease
• Prior history of cardiac surgery or ablation

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related 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;8(4):519-25. doi: 10.1016/j.hrthm.2010.12.022. Epub 2010 Dec 15.

  PMID: 21167315 RESULT

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Christina Miyake
• Organization: Children's Hospital Boston

cymiyake@bcm.edu

832-826-5650

Study Officials

• Christina Y. Miyake, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Model Details: 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

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: January 9, 2009
• Primary Completion: September 28, 2009
• Study Completion: May 28, 2010
• Last Updated: March 8, 2018
• Results First Posted: March 8, 2018

Record last verified: 2018-02

Locations

US (1)