ICE: Intracardiac Ultrasound Within the Left Atrium During Radiofrequency Ablation of Nonvalvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- number of lesions requiring ablation to obtain Electrical Isolation PV System
研究概览
简要总结
Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation
详细描述
Atrial fibrillation is the most common rhythm disturbance affecting the human population.
- Its prevalence increases with age and can be found in >8% of humans over the age of eighty;
- Radiofrequency ablation for drug refractory nonvalvular atrial fibrillation has become a common therapy available to patients. It has been shown to be both efficacious and cost effective;
- The standard approach to atrial fibrillation involves electrical isolation of the pulmonary veins (PVI) from the rest of the atrium chamber. This involves moving a 3.5mm tip ablation catheter point to point around the PV structures until an encircling ablation line is formed. This can be made difficult by not knowing if the tip is in good contact with the atrial tissue. In addition the esophagus is a posterior lying structure and injury to the esophagus by ablating the overlying tissue has been reported, at times fatal;
- Currently, intracardiac imaging of the left atrium has FDA approval in the right atrial chamber. This leads to difficulty in visualizing tip tissue interface, and important left sided structures such as carina, ligaments, and esophagus. By placing the tip of the ICE catheter in the left atrium, enhanced visualization of the tip tissue interface may lead to more effective ablation points, fewer needed ablation points, and enhanced safety by avoiding placement over adjacent noncardiac structures.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Recommended for radiofrequency ablation of nonvalvular atrial fibrillation
排除标准
- 未提供
研究组 & 干预措施
Study arm
The study arm group will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.
干预措施: Biosense Webster irrigated tip catheter (Device)
Study arm
The study arm group will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.
干预措施: ICE catheter placed through one of two existing 8F sheaths (Procedure)
Control arm
The control arm group will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.
干预措施: Biosense Webster irrigated tip catheter (Device)
Control arm
The control arm group will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.
干预措施: Pulmonary vein isolation (Procedure)
结局指标
主要结局
number of lesions requiring ablation to obtain Electrical Isolation PV System
时间窗: during procedure
to assess the number of lesions requiring ablation to obtain Electrical Isolation PV system
次要结局
- to assess number of lesions to obtain Electrical Isolation PV system(during procedure)
研究者
Gregory Jones
Gregory Jones, MD, FACC
Wellmont CVA Heart Institute