Arrhythmias & electrophysiology

Left Atrial Appendage Occlusion Versus NOACs in patients With Atrial Fibrillation: Rationale and Design of the CATALYST Trial

Am Heart JPublished prospective, multicenter, randomized controlled, open-label trial with an adaptive statistical design

Study context

Population
Atrial fibrillation (AF) patients with CHA2DS2-VASc score ≥2 (men) or ≥3 (women) indicated for thromboprophylaxisplanned enrollment (design paper)
Participants
Up to 2,650 patients
Planned comparison
a dual-seal left atrial appendage occlusion (LAAO) device (Amplatzer™ Amulet™) to NOACs in AF patients indicated for thromboprophylaxis
Primary endpoint
Three co-primary endpoints: (1) ischemic stroke, systemic embolism, or cardiovascular death through 2 years, tested for noninferiority; (2) major or clinically relevant nonmajor bleeding through 2 years, tested for superiority; (3) ischemic stroke or systemic embolism through 3 years, tested for noninferiority
Follow-up
2 years; 3 years
Methodological details123 global sites
  • 123 global sites

No results yet. This paper sets out the design of a trial; its results are to come.

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Left Atrial Appendage Occlusion Versus NOACs in patients With Atrial Fibrillation: Rationale and Design of the CATALYST Trial. Am Heart J. Published 2 February 2026. doi:10.1016/j.ahj.2026.107367

Summarised from the published abstract; every number is checked against it

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