NCT04954911已完成不适用
Prospective, Multi-centre, Observational Registry to Evaluate the Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kardium Inc.
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Freedom from AF at 12 months following ablation with the Globe System
研究概览
简要总结
This is an observational, multicentre, prospective, post-market product registry for participants with AF for whom ablation by the commercially available Globe Mapping and Ablation System was indicated before enrolment into the registry. The aim of the registry is to confirm the clinical performance and safety of the Globe Mapping and Ablation System in a real-life setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry
- •Signed informed consent
排除标准
- •Contraindication for catheter ablation with the Globe System
- •Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
- •Physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.
结局指标
主要结局
Freedom from AF at 12 months following ablation with the Globe System
时间窗: Up to 1 year
Freedom from AF/AFL/AT at 12 months following ablation with the Globe System
时间窗: Up to 1 year
Device- and procedure-related adverse events within 12 months following ablation with the Globe System
时间窗: Up to 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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