THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 40
- 主要终点
- Incidence of Primary Adverse Events Within Specified Study Period
研究概览
简要总结
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
详细描述
The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.
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
- •Have had at least 3 atrial fibrillation episodes within 6 months of this study
- •Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
- •18 years of age or older
- •Exclusion Criteria including, but not limited to:
- •Have had previous ablation for atrial fibrillation
- •Have take amiodarone within 6 months of this study
- •Have had any heart surgery within the last 60 days
- •Have had a heart attack within the last 60 days
- •Females who are pregnant or breast feeding
排除标准
- 未提供
结局指标
主要结局
Incidence of Primary Adverse Events Within Specified Study Period
时间窗: 12 months post procedure
Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
时间窗: Day 91-361
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures
次要结局
- Late Onset Serious Adverse Events(From 31 days post procedure to month 12)
- Peri-procedural Serious Adverse Events(Within 8-30 days post procedure)
- Percentage of Subjects Achieved Acute Effectiveness(5 hours of procedure time)