NCT00449085撤回2 期
Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.
详细描述
To construct geometric representation of the heart chambers using intracardiac ultrasound.The Carto™ XP Electrophysiology (EP) Navigation System v9 is intended to acquire real-time catheter based cardiac electrophysiogical maps.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing any EPS study and or Ablation will be eligible for this study.
- •Age 18 years or older Signed Patient Informed Consent Form
排除标准
- •Patients with inadequate vascular access
- •Patients with any of the following criteria will be excluded:
- •Women who are pregnant
- •Age <18 years
- •Any Contraindication to the clinical procedure
- •Major coagulation abnormalities
- •Presence of any intracardiac thrombus
- •Unstable angina
- •Uncontrolled Heart failure
- •Deep Vein Thrombosis
- •Significant peripheral vascular disease
研究者
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