Left Atrial Appendage closure: Percutaneous closure of the LAA
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
"Net clinical benefit" — Day 0 "Net clinical benefit", defined as, time to first stroke (including ischemic or hemorrhagic strokes), systemic embolism, cardiovascular or unexplained death or major bleeding (BARC 3-5)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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