RecruitingNot Applicable

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

Germany430 participantsStarted 2022-03-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

"Net clinical benefit"

Timeframe: Day 0

Trial details

NCT IDNCT05204212

SponsorProf. Dr. med. Ingo Eitel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-14

Contact for this trial

Ingo Eitel, MD

+49 451 500 44501 ingo.eitel@uksh.de

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent trials