Closure of the left atrial appendage in patients with atrial fibrillation and severe kidney disease
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Trial ID | NCT05204212 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented NVAF and end-stage renal disease.
Not a fit: Patients with contraindications to anticoagulation therapy or other significant comorbidities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lübeck, Schleswig-Holstein
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.