Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 30
- 主要终点
- Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
研究概览
简要总结
The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
- •Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
- •Left atrial diameter < 6.0 cm
排除标准
- •Previous AF Ablation
- •Presence of structural heart disease
- •New York Heart Association (NYHA) Class IV.
- •Ejection fraction < 35%.
- •History of myocardial infarction (MI) within the past three months.
结局指标
主要结局
Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure
时间窗: Within 7-10 days of the Procedure
Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.
时间窗: 3-month follow up
Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.
时间窗: 3-12 months post study treatment
Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure
时间窗: 3 to 12 months post study treatment
次要结局
- Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts(Immediately post procedure)