Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 60
- 主要终点
- Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
研究概览
简要总结
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
详细描述
The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 diagnosed as having migraine headaches both with and without aura
- •Have a Patent Foramen Ovale (PFO)
- •A migraine history and show a refractoriness to medical treatment
- •Willing to participate in follow-up visits
排除标准
- •Subjects whose primary headaches are other than migraine headaches
- •Who overuse migraine treatments
- •With a clinical history of stroke or Transient Ischemic Attack (TIA)
- •With contraindication to aspirin therapy and Clopidogrel
- •Pregnant or desire to become pregnant within the next year
结局指标
主要结局
Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
时间窗: Baseline through 12 months
Number of subjects who experience a device-related major adverse event (DRMAE) through 12-months of follow-up. This endpoint was analyzed using an as-treated cohort that consists of all enrolled subjects who received the device (randomized and Optional PFO Closure group) and who had follow-up sufficient to adequately assess the DRMAE rate.
Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.
时间窗: Baseline and months 10-12
A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).
次要结局
- Incidence of Device-related Adverse Events(12 months)
- Change in Mean Migraine Days/Month(Baseline and months 10-12)
- Long-Term Success(12 months)
- Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months(12 months)
- Incidence of a 75% Reduction in Migraine Headache Attacks(12 months)
- Procedural Success(12 months)
- Incidence of All Adverse Events at 12-months(12 months)
- Incidence of a 95% Reduction in Migraine Headache Attacks(12-months)
- Percentage of Subjects With Successful PFO Closure at 12-months(Baseline and month 12)