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
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00979303
First received: September 17, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 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

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
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 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):
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 August 27, 2014