Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Recruiting · NCT05204212 · Interventional (participants receive a specific treatment) · Lead sponsor: Prof. Dr. med. Ingo Eitel
View the official record on ClinicalTrials.gov →Interventions studied
Left Atrial Appendage closure
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Universität zu Lübeck - Lübeck, Schleswig-Holstein, Germany
- Universität zu Lübeck - Lübeck, Schleswig-Holstein, Germany