The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Total Fluoroscopy Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/=8
- •Weight >/=25kg
- •Structurally normal heart (no major cardiac defects)
- •History of SVT
- •No prior history of cardiac surgery or ablation
排除标准
- •Congenital Heart Disease
- •Prior history of cardiac surgery or ablation
研究组 & 干预措施
Control Group
Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
Study Group
Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.
干预措施: Intracardiac echocardiography and 3D navigational system (Device)
结局指标
主要结局
Total Fluoroscopy Time
时间窗: During the Ablation procedure
Total fluoroscopy time in minutes
次要结局
- Total Radiation Exposure(During Ablation Procedure)
研究者
Christina Yumi Miyake
Fellow
Boston Children's Hospital