NCT04519112Unknown4 期
Department of Cardiology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- Freedom rate of PVC
研究概览
简要总结
This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •non-outflow tract PVCs
- •Holter>10,000/24h or PVCs load>10%
- •the first ablation procedure
- •failure of at least one AAD to treat PVCs before ablation
排除标准
- •PVC ablation history
- •HF with NYHA IV
- •3 months prior to AMI or PCI
- •Cardiac thrombosi
- •Hyperthyroidism
研究组 & 干预措施
Mannual control navigation group
Active Comparator
PVC ablation with mannual navigation
干预措施: Catheter Ablation (Procedure)
Remote magnetic navigation group
Experimental
PVC ablation with RMN
干预措施: Catheter Ablation (Procedure)
结局指标
主要结局
Freedom rate of PVC
时间窗: one year
Efficacy endpoint
Procedure-related Complications
时间窗: one year
Safety endpoint
次要结局
- ablation time(one day)
- procedure time(one day)
- fluoroscopic time(one day)
研究者
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