NCT02514876已完成早期 1 期
Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Conavi
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
研究概览
简要总结
This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.
详细描述
This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years old.
- •Patient is undergoing an atrial fibrillation ablation procedure.
- •Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
- •Patient provides informed, written consent for participation in the study.
排除标准
- •Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure).
- •Patients in whom transseptal puncture is relatively contraindicated.
- •Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
- •Women of child bearing potential, in whom pregnancy cannot be excluded.
- •Patients unable to grant informed, written consent for participation in the study.
结局指标
主要结局
Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
时间窗: During ablation procedure (2-4 h)
次要结局
未报告次要终点
研究者
研究点 (2)
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