Amplatzer PFO Occluder Post-marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- PE, DVT and ischemic stroke and atrial fibrillation rate
研究概览
简要总结
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
详细描述
Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refer to Amplatzer PFO occluder IFU
排除标准
- •Refer to Amplatzer PFO occluder IFU
结局指标
主要结局
PE, DVT and ischemic stroke and atrial fibrillation rate
时间窗: beyond 30 days through 3 years
rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years
Effective PFO closure
时间窗: At 1 year
Effective closure of the PFO at 1 year
device- or procedure related SAE rate
时间窗: up to 30 Days
device- or procedure related serious adverse events (SAEs) through 30 days
次要结局
未报告次要终点