THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 主要终点
- The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.
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
排除标准
- •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
研究组 & 干预措施
THERMOCOOL® SMARTTOUCH™ Catheter
干预措施: THERMOCOOL® SMARTTOUCH™ Catheter (Device)
结局指标
主要结局
The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
时间窗: 12-months
The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
时间窗: 7 days of the AF ablation procedure
Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.
次要结局
- Rate of Acute Success(End of procedure)