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

Recruiting now · Not applicable

Conditions studied: Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent

In brief

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.

Key facts

Study ID

NCT05204212

Run by

Prof. Dr. med. Ingo Eitel

People needed

430

Starts

2022-03-28

Expected to finish

2028-01-14

Last updated by the study team

2024-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Universität zu Lübeck — Lübeck, Schleswig-Holstein, Germany (enrolling)

Full record on ClinicalTrials.gov

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