Clinical Trial

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

Study acronym: LAA-KIDNEY
Recruiting
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Record status
This record was last updated May 13, 2024 (before its estimated January 14, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-01-10; most recent amendment 2024-05-10.
Status change: Not Yet Recruiting → Recruiting 2022-05-17
Trial Details
NCT Number NCT05204212
Lead Sponsor Prof. Dr. med. Ingo Eitel
Conditions Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Enrollment 430 participants
Start Date 2022-03-28
Primary Completion 2026-01-14 (estimated)
Study Completion 2028-01-14 (estimated)
Updated on ClinicalTrials.gov 2024-05-13