Actively Recruiting
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Led by Prof. Dr. med. Ingo Eitel · Updated on 2024-05-13
430
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E�3D 18 years
- Ability to give informed consent
- Documented non-valvular atrial fibrillation (paroxysmal, persistent, or permanent)
- CHA2DS2VASc risk score �3E�3D 2
- Chronic kidney disease KDOQI stage 5 (eGFR <15 ml/min/1.73m2) with or without hemodialysis
You will not qualify if you...
- Absolute contraindication to aspirin and/or clopidogrel
- Comorbidities other than atrial fibrillation requiring chronic (N)OAC therapy, such as mechanical heart valve prosthesis
- Presence of left atrial appendage thrombus
- Mobile aortic atheroma
- Age less than 18 years
- Pregnancy
- Lack of informed consent
- Participation in another trial
- Expected life expectancy less than 2 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
Research Team
I
Ingo Eitel, MD
CONTACT
T
Thomas Stiermaier, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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