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

RecruitingNAAges 18 Years - anyAllProf. Dr. med. Ingo Eitel
NCT05204212 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Left Atrial Appendage closure
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Where

1 site
Universität zu Lübeck
Lübeck, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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