Left Atrial Appendage Closure During Cardiac Surgery in Atrial Fibrillation Patients Using the Seralene AtriLASH Device

What this Trial Is About

Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke due to blood clots forming in a small heart structure called the left atrial appendage. Blood-thinning medicines are often prescribed to lower stroke risk, but some patients cannot use them long-term because of bleeding or side effects. This research evaluates the safety and effectiveness of closing the left atrial appendage during cardiac surgery using a device called AtriLASH, which is designed to reduce stroke risk in patients with atrial fibrillation undergoing surgery. The study involves patients with atrial fibrillation who are scheduled for cardiac surgery and have a stroke risk score (CHA₂DS₂-VASc) of 2 or higher. During their planned surgery, the left atrial appendage will be closed using the AtriLASH device, a surgical suture-based tool made of Seralene material. This closure is performed as part of the same operation without additional procedures, aiming to prevent blood from collecting in the appendage. Participants will be monitored after surgery to assess whether the left atrial appendage remains closed and to observe any major events such as stroke, embolism, bleeding, or death within three months post-surgery. The study includes assessments related to the device's success and patient safety. Total participation covers the surgical procedure and follow-up evaluations up to three months after surgery to gather important information about this treatment approach.

Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture