NCT01341353Unknown4 期
Atrial Fibrillation Therapy: A Multi-Center Clinical Study
Wuhan University1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Number of participants with all-cause death
研究概览
简要总结
The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter ablation has increasingly been used over the last decades. The relative merits of each strategy have not been extensively studied. Our study was designed to determine if catheter ablation is a feasible option as first-line therapy for treating patients with symptomatic AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 Patients with symptomatic AF recorded by ECG or Holter 2 Age:18-75 years 3 Patients who are willing to enroll in the trial
排除标准
- •1 Patients accompanied hyperthyroidism 2 Patients with sever liver or renal dysfunction 3 Patients with sever cardiac dysfunction 4 Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure 5 Patients with emboli in atrium 6 Pregnant woman
研究组 & 干预措施
Antiarrythmic Drugs
Active Comparator
干预措施: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists (Drug)
ablation
Experimental
干预措施: catheter ablation (Procedure)
结局指标
主要结局
Number of participants with all-cause death
时间窗: 36 month
severe blooding complications
时间窗: 36 month
cardio-cerebrovascular complications
时间窗: 36 month
Number of participants with cardiovascular death events
时间窗: 36 month
次要结局
- recurrence of atrial arrhythmias (AF, AFL, AT)(36 month)
- resource utilization and costs(36 month)
研究者
研究点 (1)
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