NCT01997736已完成不适用
A Pilot Study Evaluating the Safety and Effectiveness of the Toray Satake Balloon Thermal Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Occurrence of major complications
研究概览
简要总结
The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
- •≥2 Symptomatic atrial fibrillation episodes
- •At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND
- •At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation
- •No episode >7 days
- •Failed to respond to or is intolerant of ≥1 Class I, II, III or IV antiarrhythmic drug
- •Able and willing to provide informed consent and Health Insurance Privacy and Portability Act (HIPAA) authorization
- •Able and willing to meet all study requirements, including attending all post-ablation procedure assessments and visits
排除标准
- •Left atrium ≥50 mm
- •Chronically used amiodarone in the 3 months prior to enrollment
- •Previous left atrial ablation or surgical treatment for atrial fibrillation
- •Left ventricular ejection fraction (LVEF) <35 %
- •New York Heart Association (NYHA) Class III or IV heart failure
- •History of myocardial infarction (MI) or unstable angina in the 6 months prior to enrollment
- •Multiple other exclusion criteria to establish overall good health and likely study compliance
结局指标
主要结局
Occurrence of major complications
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (7)
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