Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation

What is the Purpose of this Study?

This study focuses on patients with non-valvular atrial fibrillation who are at increased risk of stroke and eligible for left atrial appendage (LAA) closure. The purpose of the study is to evaluate the safety and feasibility of an investigational device called the Append System with its associated procedure and observe the system performance in isolating the pouch of the LAA from the left atrium of the heart. The LAA is a small pouch-like structure located on the left side of the heart where blood clots can form, which may cause stroke, particularly in patients with atrial fibrillation. In the Append procedure, the LAA is folded into the LA and tied off with a suture, resulting in complete elimination of the LAA pouch. This treatment may have the benefit of reducing the risk for ischemic stroke (blood clot to the brain) or systemic embolism (blood clot in other parts of the body). Participants will be monitored following the procedure and will complete related assessments and tests.