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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-09

Study Completion Date

2010-05-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Supraventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Control Patients - Undergo ablation procedures with radiation/fluoroscopy only

Group Type NO_INTERVENTION

No interventions assigned to this group

Study Group

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

Group Type EXPERIMENTAL

Intracardiac echocardiography and 3D navigational system

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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AcuNav Intracardiac Echocardiography NavX 3D navigational system CARTO 3D navigational system

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Christina Yumi Miyake

Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Y. Miyake, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 21167315 (View on PubMed)

Study Documents

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Document Type: Archived consent, protocol and analytic plan.

Study completed prior to change in common rule. Requests should be directed to the investigation team at Boston Children's Hospital through [email protected]

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