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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.
The purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) and end-stage renal failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental intervention | Experimental | Percutaneous closure of the LAA by use of the CE-mark approved LAA exclusion device Amplatzer Cardiac Plug or Amulet followed by dual antiplatelet therapy with aspirin 100mg od and clopidogrel 75 mg od for 3 months. In patients with excessive bleeding risk DAPT duration can be shortened according to the physicians' discretion to a minimum of 6 weeks. Oral anticoagulants are not prescribed in this group. |
|
| Control intervention | No Intervention | No catheter-based LAA closure. Treatment with best medical care (warfarin or NOAC therapy or other best medical care if (N)OAC therapy is contraindicated). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Atrial Appendage closure | Other | Percutaneous closure of the LAA |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Net clinical benefit" | "Net clinical benefit", defined as, time to first stroke (including ischemic or hemorrhagic strokes), systemic embolism, cardiovascular or unexplained death or major bleeding (BARC 3-5) | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingo Eitel, MD | Contact | +49 451 500 44501 | ingo.eitel@uksh.de | |
| Thomas Stiermaier, MD | Contact | +49 451 500 44501 | thomas.stiermaier@uksh.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität zu Lübeck | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42107551 | Derived | Saraei R, Heine GH, Osmancik P, Schewel J, Sandri M, Landmesser U, Schwenger V, Latus J, Bekeredjian R, Chun J, Haeusler KG, Paitazoglou C, Sigusch H, Thiele H, Skurk C, Rychlik I, Schmidt B, Stiermaier T, Schneider S, Eitel I. Left atrial appendage closure in patients with non-valvular atrial fibrillation and end stage chronic KIDNEY disease: Rationale and design of the prospective randomized LAA-KIDNEY trial. Am Heart J. 2026 Oct;300:107474. doi: 10.1016/j.ahj.2026.107474. Epub 2026 May 8. |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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