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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 Boston Children’s Hospital.
Recruitment status was  Recruiting
Information provided by:
Boston Children’s Hospital Identifier:
First received: September 17, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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 4

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:

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

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


Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00979303

Contact: Christina Y. Miyake, MD 617-355-6432
Contact: John K. Triedman, MD 617-355-6432

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
Boston Children’s Hospital
Principal Investigator: Christina Y. Miyake, MD Boston Children’s Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christina Miyake, MD Principal Investigator, Children's Hospital Boston 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 Boston Children’s Hospital:

Additional relevant MeSH terms:
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on October 21, 2016