LAA Closure for Atrial Fibrillation in Kidney Disease
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Recruiting
N/A
Interventional Study
Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 430 (estimated)
- Sponsor
- Prof. Dr. med. Ingo Eitel · Other
Who this trial is looking for
This trial is looking for adults with a heart condition called non-valvular atrial fibrillation and end-stage kidney disease. Participants will receive a device to help prevent strokes, alongside their usual medical care.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I can give informed consent.
- I have been diagnosed with non-valvular atrial fibrillation.
- I have a CHA2DS2VASc risk score of 2 or higher.
- I have stage 5 chronic kidney disease.
You may not be able to join if
- I cannot take aspirin or clopidogrel.
- I have other health issues requiring ongoing anticoagulation therapy.
- I currently have a blood clot in my heart.
- I have a moving aortic atheroma.
- I am pregnant.
- I am participating in another trial.
- I have a life expectancy of less than 2 years.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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…
Trial Locations
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Eligibility Criteria
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 contraindicatio…
Contacts