Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
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
- •Age 18-75 years
- •One documented occurrence of typical AFL within the past 6 months
- •Be able and willing to sign informed consent
排除标准
- •Contraindication to a non-emergent interventional EP procedure
- •Require treatment in or access to left atrium
- •Had a myocardial infarction within the prior two months
- •Had cardiac surgery within the prior three months
- •Intracardiac thrombus
- •Permanent pacemaker/ICD leads in/through right atrium
- •Clinically significant tricuspid valve regurgitation or stenosis
- •Cerebral ischemic event (including TIA) in the prior six months
- •Currently enrolled in any other clinical investigation
- •Any other significant uncontrolled or unstable medical condition
结局指标
主要结局
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
时间窗: 3 months post-procedure
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.
The number of patients that experience a device-related adverse events as a measure of safety and tolerability
时间窗: 7 days post-procedure
次要结局
未报告次要终点