NCT01716663已完成不适用
CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 26
- 主要终点
- Total Fluoroscopy Time
研究概览
简要总结
This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
详细描述
This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Drug refractory, recurrent symptomatic paroxysmal AF
- •Age 18 years or older
- •Patients able and willing to provide written informed consent to participate in the study and comply with study requirements
排除标准
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Previous ablation for atrial fibrillation
- •AF episodes that last longer than 30 days
- •Uncontrolled heart failure, or NYHA Class III or IV heart failure
- •Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
- •Contraindication to anticoagulation
- •Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- •Awaiting cardiac transplantation
- •Heart disease for which corrective surgery is anticipated within 6 months
- •Enrollment in other investigational drug or device study
- •Subjects unwilling to comply with protocol or follow-up requirements
- •Patients who are pregnant
结局指标
主要结局
Total Fluoroscopy Time
时间窗: Day 0
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
次要结局
- Total Procedure Time(Day 0)
- Acute Procedural Success(Day 0)
- Mean Number of Radiofrequency (RF) Applications(Day 0)
- Total Radiofrequency (RF) Time(Day 0)
研究者
研究点 (26)
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