Study of Minimally Invasive Left Atrial Appendage Closure to Prevent Embolic Events in Adults with Non-valvular Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a device called the LAmbre2 Left Atrial Appendage Occluder System for patients with non-valvular atrial fibrillation AF who have had previous embolic events such as ischemic stroke, transient ischemic attack TIA, or systemic embolism. This multicenter, prospective, non-interventional study involves 579 patients across about 20 sites and aims to assess whether this procedure can serve as secondary prevention for AF-related embolic events. The study involves observing patients undergoing percutaneous left atrial appendage closure using the LAmbre2 device. Data is collected on baseline health, the operation process, and follow-up information at multiple time points before discharge or 7 months after the procedure, then at 1, 3, 6, 12, and 24 months after the operation. The only intervention mentioned is transthoracic echocardiography, which is used to collect data during eight follow-up visits. Participants will have regular hospital visits for assessments including echocardiography and other clinical evaluations at scheduled intervals up to 24 months after the procedure. Researchers will monitor the incidence of new ischemic strokes, systemic embolisms, cardiac deaths, major bleeding events, surgery success rates, and any complications related to the procedure or device. Safety and effectiveness will be tracked through these measures to better understand outcomes after left atrial appendage closure in this patient group.

Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events