Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of Conversion to surgical procedure
研究概览
简要总结
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
- •Diagnosed with a PFO
- •Note: Additional Inclusion Criteria may apply
排除标准
- 未提供
结局指标
主要结局
Rate of Conversion to surgical procedure
时间窗: Discharge
Rate of post-procedure conversion to surgical procedure will be calculated.
PFO Closure Rate
时间窗: 12 months
PFO closure success will be defined as the number of cases which achieve effective PFO closure at 12 months post-initial procedure out of those which complete the PFO closure evaluation under Trans-Thoracic Echocardiography (TTE) with bubbles. PFO effective closure will be defined as the number of bubbles confirmed to be less than 20 (\<20).
Incidence rate of post-procedure ischemic stroke events
时间窗: 36 months
Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot.
Incidence rate of device- and procedure-related events within 30 days post procedure
时间窗: 30 days
Incidence rate of adverse events and/or device issues which are defined as device- or procedure-related within 30 days post procedure will be calculated.
Incidence rate of post-procedure adverse events and/or device issues
时间窗: 36 months
Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated.
Device success
时间窗: 36 months
Device success will be calculated by the number of cases with successful device implant during the initial procedure and later follow-ups out of those which underwent the transcatheter PFO closure procedure.
次要结局
未报告次要终点