The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- PFO closure 6 months post procedure
研究概览
简要总结
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.
详细描述
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old
- •Documented PFO
- •Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness
排除标准
- •Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
结局指标
主要结局
PFO closure 6 months post procedure
时间窗: 6 months
次要结局
- PFO closure at 30 days and 12 months post procedure(30 days, 12 months)
- AE event rates for all subjects(30 days, 6 and 12 months)
- Migraine severity(6 and 12 months)