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

  • STATUS
    Recruiting
  • End date
    Jan 14, 2026
  • participants needed
    430
  • sponsor
    Prof. Dr. med. Ingo Eitel
Updated on 9 June 2022

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.

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.

Details
Condition Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Treatment Left atrial appendage closure
Clinical Study IdentifierNCT05204212
SponsorProf. Dr. med. Ingo Eitel
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Ability to give informed consent
Documented NVAF (paroxysmal, persistent, or permanent)
CHA2DS2VASc risk score ≥2
Chronic kidney disease KDOQI stage 5 (eGFR <15 ml/min/1.73m2) with or without hemodialysis

Exclusion Criteria

Absolute contraindication to aspirin and/or clopidogrel
Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
Present LAA thrombus
Mobile aortic atheroma
Age ≤18 years
Patients presenting with pregnancy
Patients without informed consent
Participation in another trial
Expected life expectancy <2 years
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