Arrhythmias & electrophysiologyTrial design
Left Atrial Appendage Occlusion Versus NOACs in patients With Atrial Fibrillation: Rationale and Design of the CATALYST Trial
- prospective, multicenter, randomized controlled, open-label trial with an adaptive statistical design
- 123 global sites
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
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