Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease

Prospective, Randomized, Controlled, Unblinded, International, Multicentre, Parallel Two Group Trial of Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage

In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and/or Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.

The purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) and end-stage renal failure.

Inclusion Criteria:

• Age ≥ 18 years
• Ability to give informed consent
• Documented NVAF (paroxysmal, persistent, or permanent)
• CHA2DS2VASc risk score ≥2
• Chronic kidney disease KDOQI stage 5 (eGFR <15 ml/min/1.73m2) with or without hemodialysis

Exclusion Criteria:

• Absolute contraindication to aspirin and/or clopidogrel
• Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
• Present LAA thrombus
• Mobile aortic atheroma
• Age ≤18 years
• Patients presenting with pregnancy
• Patients without informed consent
• Participation in another trial
• Expected life expectancy <2 years