Left atrial appendage closure in patients with non-valvular atrial fibrillation and end stage chronic KIDNEY disease: Rationale and design of the prospective randomized LAA-KIDNEY trial

BACKGROUND: Patients with atrial fibrillation (AF) and kidney failure are at particularly high risk of both thromboembolic and bleeding complications. The safety and efficacy of oral anticoagulation in this population remain uncertain, as pivotal direct oral anticoagulant (DOAC) trials excluded patients with kidney failure and warfarin has been associated with excess bleeding risk. Left atrial appendage (LAA) closure may provide an alternative strategy in stroke prevention, but has not been tested in randomized trials in dialysis-dependent patients. METHODS/DESIGN: The LAA-KIDNEY trial is a prospective, multicenter, randomized controlled clinical trial comparing percutaneous LAA closure with best medical care (including DOAC therapy whenever considered feasable) in patients with non-valvular AF and kidney failure at high risk of both, ischemic stroke and bleeding. A total of 272 patients will be randomized 1:1 across ∼35 centers in Germany, Belgium and the Czech Republic. The primary efficacy endpoint is net clinical benefit defined as time to a composite of first stroke (including ischemic or hemorrhagic strokes), systemic embolism, cardiovascular or unexplained death or major bleeding (BARC 3-5). Secondary endpoints include individual components of the composite outcome, myocardial infarction, cardiovascular hospitalization, cognitive function, quality of life, and device-related complications. Analysis will be performed in the intention-to-treat population. CONCLUSION: LAA-KIDNEY is the first randomized trial to evaluate LAA closure versus best medical care in AF patients with kidney failure. This trial will address a major evidence gap and is expected to inform clinical practice and guideline recommendations for stroke prevention in this high risk population. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05204212.