Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 33
- 主要终点
- Migraine headache frequency
研究概览
简要总结
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
详细描述
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Subjects who are age 18 to 65
- •Subjects who have migraine headaches with aura diagnosed by a doctor
- •Subjects who have not responded to or cannot take common migraine preventive medications
排除标准
- •Subjects with a clinical history of stroke
- •Subjects who cannot take aspirin and clopidogrel (Plavix)
- •Subjects who are pregnant or desire to become pregnant within the next year
研究组 & 干预措施
Medical Management
PFO Closure
干预措施: AMPLATZER® PFO Occluder Device (Device)
结局指标
主要结局
Migraine headache frequency
时间窗: 12 months
次要结局
- Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure(12 months)