drugset / Trial / NCT03463317
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy
Phase 4
Completed
912 enrolled
Charite University, Berlin, Germany
Atrial Fibrillation Network · collabDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) · collabStiftung Institut fuer Herzinfarktforschung · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a \[non-vitamin K\] oral anticoagulant \[(N)OAC\] when eligible).
Timeline
- Start
- 2018-02-28
- Primary completion
- 2024-11-30
- Completion
- 2024-11-30
Publications
- Claus F, Muller M, Fass E, Diesing J, Skurk C, Seppelt C, Meteva D, Rroku A, Eitel I, Boldt LH, Landmesser U, Wille E, Weinhold I. Health economic evaluation of left atrial appendage closure in patients with atrial fibrillation and at high risk for stroke and bleeding: a study protocol. Front Health Serv. 2026 Jul 1;6:1771683. doi: 10.3389/frhs.2026.1771683. eCollection 2026.
- Landmesser U, Skurk C, Kirchhof P, Lewalter T, Hartung J, Rroku A, Pieske B, Brachmann J, Akin I, Jacobshagen C, Meder B, Zeiher A, Anker SD, Thiele H, Blankenberg S, Massberg S, Schunkert H, Frey N, Joost A, Bergmann M, von Bardeleben RS, Friede T, Placzek M, Suling A, Haeusler KG, Endres M, Wegscheider K, Boldt LH, Eitel I; CLOSURE-AF Trial Investigators. Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation. N Engl J Med. 2026 Apr 2;394(13):1270-1280. doi: 10.1056/NEJMoa2513310. Epub 2026 Mar 18.
- Landmesser U, Skurk C, Kirchhof P, Lewalter T, Hartung J, Rroku A, Pieske B, Brachmann J, Akin I, Jacobshagen C, Meder B, Zeiher A, Anker SD, Thiele H, Blankenberg S, Massberg S, Schunkert H, Frey N, Joost A, Bergmann M, Haeusler KG, Endres M, Wegscheider K, Boldt LH, Eitel I. Catheter-based left atrial appendage CLOSURE in patients with atrial fibrillation at high risk of stroke and bleeding as compared to best medical therapy: Rationale and design of the prospective randomized CLOSURE-AF trial. Am Heart J. 2026 Feb;292:107273. doi: 10.1016/j.ahj.2025.09.005. Epub 2025 Sep 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apixaban | Small molecule | — | — |
| Comparator | Dabigatran | Unknown | — | — |
| Comparator | Edoxaban | Small molecule | — | — |
| Comparator | Phenprocoumon | Small molecule | — | — |
| Comparator | Rivaroxaban | Other / unclassified | — | — |
| Comparator | Warfarin | Small molecule | — | — |
| Background | Aspirin | Small molecule | — | — |
| Background | Clopidogrel | Small molecule | — | — |