Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Atrial fibrillation
研究概览
简要总结
This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.
详细描述
This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke. Secondary objectives include assessment of the burden of AF at 2, 12 and 24 months after PFO closure; evaluation of the relationship between plasma levels of MR proANP and presence of AF within 2 years after percutaneous PFO closure in patients with a history of cryptogenic ischemic stroke; and description of recurrence rates for stroke (ischemic and hemorrhagic), major bleeding, minor bleeding, peripheral emboli during the 2-year follow-up period after percutaneous PFO closure, in patients with and without AF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged >18 years)
- •with an indication for percutaneous closure of PFO due to cryptogenic stroke, with indication validated by a cardio-neurological team.
- •patients must provide written informed consent
- •patients must be affiliated to a social security regime or be a beneficiary thereof.
排除标准
- •Patients under legal protection
- •Patients not affiliated to any social security regime
- •Patients within the exclusion period of another clinical trial as per the national registry of research volunteers
结局指标
主要结局
Atrial fibrillation
时间窗: Within 2 months after percutaneous PFO closure
Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)
次要结局
- Atrial fibrillation(Within 24 months after percutaneous PFO closure)
- Burden of atrial fibrillation(Within 2 years after percutaneous PFO closure)
- Relation between MR proANP levels and atrial fibrillation(Within 2 years after percutaneous PFO closure)
- Stroke(Within 2 years after percutaneous PFO closure)
- Bleeding(Within 2 years after percutaneous PFO closure)
- Peripheral emboli(Within 2 years after percutaneous PFO closure)