NCT02994446已完成不适用
Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: Within 2 days after ablation procedure
MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure).
Serious Adverse Events that are potentially device-related
时间窗: Within 30 days of ablation
Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels
时间窗: At completion of ablation procedure
次要结局
- Intraprocedural non-inducibility and/or scar homogenization of target VT(At completion of ablation procedure)
- Elimination of the target VT and/or reduction in number of VT episodes(Within first 6 months of ablation procedure)
研究者
研究点 (5)
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