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RECRUITING
NCT05204212
NA

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

Sponsor: Prof. Dr. med. Ingo Eitel

View on ClinicalTrials.gov

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

OTHER

Left Atrial Appendage closure

Percutaneous closure of the LAA

Locations (1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, Germany