NCT06026345招募中不适用
The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
Medtronic Cardiac Ablation Solutions12 个研究点 分布在 7 个国家目标入组 540 人开始时间: 2023年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 12
- 主要终点
- Primary Objective #1 (Efficacy)
研究概览
简要总结
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.
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
- •Subject is ≥ 18 years of age or minimum age as required by local regulations
- •Planned procedure using the commercially available Affera Platform
- •Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
排除标准
- •Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- •Subject with exclusion criteria required by local law
结局指标
主要结局
Primary Objective #1 (Efficacy)
时间窗: 12 Month Post Proceedure
Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.
次要结局
- Primary Objective #2 (Safety)(90 Days Post Proceedure)
研究者
研究点 (12)
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