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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
Percutaneous closure of the LAA
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany
RECRUITING"Net clinical benefit"
"Net clinical benefit", defined as, time to first stroke (including ischemic or hemorrhagic strokes), systemic embolism, cardiovascular or unexplained death or major bleeding (BARC 3-5)
Time frame: Day 0
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