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Study overview

Recruiting

SAFE LAAC CKD

Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure – Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study – PILOT

SAFE LAAC CKD study artwork

Study narrative

Clinical and operational context.

Description of the study: The main aim of the study is to compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT in patients with end-stage renal disease on chronic dialysis (randomized comparison). What is more, the study is to compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6 months after LAAC in patients with end-stage renal disease on chronic dialysis (nonrandomized comparison). The secondary objective is the assessment of safety and efficacy of transcatheter left atrial appendage occlusion in patients with end-stage renal disease on chronic dialysis (retrospective registry)