RecruitingNot ApplicableNCT05204212

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

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

Sponsor

Prof. Dr. med. Ingo Eitel

Enrollment

430 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a heart procedure called left atrial appendage closure (LAAC) — a small device implanted to prevent strokes — in patients with atrial fibrillation (an irregular heartbeat) who also have end-stage kidney disease. These patients are at high risk of stroke but can't safely take blood thinners long-term. **You may be eligible if...** - You are 18 or older - You have atrial fibrillation (irregular heartbeat) - You have end-stage kidney disease (stage 5 CKD, meaning your kidneys are working at less than 15% capacity), whether or not you are on dialysis - Your stroke risk score (CHA2DS2VASc) is 2 or higher **You may NOT be eligible if...** - You are allergic to aspirin or clopidogrel (blood thinners) - You have a mechanical heart valve - There is already a blood clot in the area of the heart where the device would be placed - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLeft Atrial Appendage closure

Percutaneous closure of the LAA

Locations(1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, Germany

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NCT05204212