NCT01914497已完成不适用
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of device-and procedure-related adverse events
研究概览
简要总结
Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 18 to 75 years
- •Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
- •Be able and willing to give informed consent
排除标准
- •Have any of the following:
- •1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.
- •1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.
- •Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
- •Have had a myocardial infarction within the prior two months
- •Have had cardiac surgery within the prior three months
- •Have an intracardiac thrombus
- •Have clinically significant tricuspid valve regurgitation or stenosis
- •Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
- •Be pregnant or nursing
- •Be currently enrolled in any other clinical investigation
研究组 & 干预措施
Acutus Medical System
Experimental
Proprietary software algorithms will be used generate electrical activation maps based dipole density data acquired by the Acutus Medical Catheter during the procedures. These activation maps will then be applied to a 3D model of the endocardial surface to create a 3D activation map.
干预措施: Acutus Medical System Mapping (Device)
结局指标
主要结局
Incidence of device-and procedure-related adverse events
时间窗: 7 days
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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