Left atrial appendage CLOSURE in patients with Atrial Fibrillation at high risk of strokeand bleeding compared to medical therapy: a prospective randomized clinical trial

07/03/2018 to 31/12/2022

Objectives: Study goal is to determine the clinical benefit of percutaneous catheter‐based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2‐VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a [non-vitamin K] oral anticoagulant [(N)OAC] when eligible).
Primary endpoint (net clinical benefit)
Survival time free of the composite of: - Stroke (including ischemic or hemorrhagic stroke) - Systemic embolism -Major bleeding (BARC type 3‐5) - Cardiovascular or unexplained death
Various secondary endpoints.