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Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Sponsor: Prof. Dr. med. Ingo Eitel
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2022-03-28
Completion Date
2028-01-14
Last Updated
2024-05-13
Healthy Volunteers
No
Interventions
Left Atrial Appendage closure
Percutaneous closure of the LAA
Locations (1)
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany