Closure of the left atrial appendage in patients with atrial fibrillation and severe kidney disease
Official title: 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
Run by University of Luebeck · NCT05204212 · Data updated 2026-11-12
This study is testing if using a special device to close a part of the heart can help people with atrial fibrillation and severe kidney disease have fewer strokes and bleeding problems compared to standard medical treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 430 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Status | Recruiting |
| Started | March 28, 2022 |
| Main results expected | January 14, 2026 |
| Study ends | January 14, 2028 |
| Registry record updated | May 13, 2024 |
| Trial ID | NCT05204212 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with documented NVAF and end-stage renal disease.
✕Probably not a fit
Patients with contraindications to anticoagulation therapy or other significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the effectiveness of left atrial appendage (LAA) closure devices compared to best medical care in patients with non-valvular atrial fibrillation (NVAF) who also have end-stage kidney disease (ESKD). Participants will be randomly assigned to receive either the LAA closure device or standard medical therapies, including anticoagulants and antiplatelet agents. The study aims to determine if LAA closure can reduce the risk of stroke and bleeding in this high-risk population. The devices being tested include the Amplatzer Cardiac Plug and Amulet, which are already clinically used.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of stroke and bleeding in patients with atrial fibrillation and severe kidney disease.
How similar studies have gone: While there have been studies on LAA closure in general, this specific approach in patients with ESKD is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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 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's running
-
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Ingo Eitel, MD
- Email: ingo.eitel@uksh.de
- Phone: +49 451 500 44501
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
LAmbre II Left Atrial Appendage Occluder in non-valvular AF patients
This trial tests whether the LAmbre II left atrial appendage occluder can be used safely in adults with non-valvular atrial fibrillation who need a non-drug option to reduce stroke risk.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.