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临床试验/NCT06983613
NCT06983613招募中不适用

New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital

Na Homolce Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital

研究概览

简要总结

Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS. When specific anatomic criteria are met, transcatheter PFO occlusion is regarded as the gold standard for secondary stroke prevention.

However, previous studies have shown that percutaneous PFO closure may increase the risk of new-onset atrial fibrillation and atrial flutter (AF), arrhythmias that elevate the risk of embolic stroke. This raises concerns about performing PFO closure. Indeed, the most common clinically significant complication after catheter-based PFO closure is AF. Available data indicates that AF typically occurs in the early period following occluder implantation, with peak incidence around the 14th day post-closure, followed by a decline after the 45th day. Although AF is considered the most frequent adverse complication after percutaneous PFO occlusion, its incidence remains relatively low, ranging from 3% to 7.4%, depending on the method used for arrhythmia screening, though this remains unclear.

In this study, investigators will prospectively monitor patients who have experienced ESUS and are indicated for PFO closure. They will be screened for the occurrence of AF following percutaneous PFO closure using a 3-week ECG Holter monitor (from day 7 to day 28 post-closure) and again 1 week (one year post-closure) after the procedure. The study aims to determine the true incidence of new-onset AF following catheter-based PFO occlusion and to identify the risk factors associated with its development.

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

  • •Indication for percutaneous closure of patent foramen ovale due to stroke, confirmed through an interdisciplinary meeting between cardiologists and neurologists, in accordance with current guidelines.
  • •Age > 18 years.
  • •Written informed consent.

排除标准

  • •Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.

结局指标

主要结局

New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital

时间窗: 2025-2028

The primary endpoint - Number of participants with at least 1 episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia), defined as any episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥ 30 seconds recorded on external cardiac monitor (ECG-Holter) during follow-up.

次要结局

  • Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) .(2025-2028)
  • Number of participants with new stroke or transient ischemic attack during follow up.(2025-2028)
  • Risk factor at baseline.(2025-2028)

研究者

发起方
Na Homolce Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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