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Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

NCT number NCT05204212
Study type Interventional
Source University of Luebeck
Contact Ingo Eitel, MD
Phone +49 451 500 44501
Status Recruiting
Phase N/A
Start date March 28, 2022
Completion date January 14, 2026