Left Atrial Appendage Closure During Cardiac Surgery in Atrial Fibrillation Patients With Seralene
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke. In patients with atrial fibrillation, blood clots most often form in a small structure of the heart called the left atrial appendage. If a blood clot travels from the heart to the brain, it can cause a stroke.
Blood-thinning medications are commonly prescribed to reduce the risk of stroke in patients with atrial fibrillation. However, some patients cannot take these medications long-term because of bleeding risk, side effects, or other medical reasons.
Closing the left atrial appendage is an alternative approach to reduce the risk of stroke by preventing blood from collecting in this area. When patients undergo cardiac surgery for another indication, closure of the left atrial appendage can be performed during the same operation.
This study is designed to evaluate the safety and effectiveness of surgical closure of the left atrial appendage using a device called AtriLASH during cardiac surgery. AtriLASH is a surgical suture-based device intended to close the left atrial appendage.
The study will assess whether the left atrial appendage can be safely and effectively closed using this method in patients with atrial fibrillation undergoing cardiac surgery. The information obtained from this study may help determine whether this approach can reduce the risk of stroke and potentially decrease the need for long-term use of blood-thinning medications in selected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Documented atrial fibrillation (any type)
- •CHA₂DS₂-VASc score of 2 or greater, or equivalent stroke risk
- •Scheduled to undergo cardiac surgery (including coronary artery bypass grafting, valve surgery, or other structural cardiac surgery)
- •Ability to understand the study and provide written informed consent
排除标准
- •Contraindication to left atrial appendage closure (e.g., presence of left atrial appendage thrombus or unsuitable anatomy)
- •Life expectancy less than 3 months, based on clinical judgment
- •Current participation in another clinical study that could interfere with the outcomes of this study
- •Active or suspected infective endocarditis
研究者
Lazar Velicki
Professor, Senior Attending Cardiac Surgeon
Institute of Cardiovascular Diseases, Vojvodina