Arrhythmias & electrophysiology
Rationale and design of a randomized study comparing the Watchman FLX device to direct OACs (DOACs) in patients with atrial fibrillation
Study context
- Population
- Patients with atrial fibrillation (AF) indicated for OAC, CHA2DS2-VASc ≥2 (men) or ≥3 (women)
- Participants
- 3,000 patients142 global sites
- Planned comparison
- LAAC with Watchman FLX vs DOAC
- Primary endpoint
- (1) Composite of stroke (ischemic/hemorrhagic), CV death and systemic embolism (non-inferiority); (2) nonprocedural bleeding (ISTH major and clinically relevant nonmajor) (superiority); (3) composite of ischemic stroke and systemic embolism at 5 years (non-inferiority)
- Follow-up
- 3 years (end points 1 and 2); 5 years (end point 3)
Methodological detailsnon-inferiority, superiority, 1:1 allocation, multicentre (142 global sites), Follow-up at 3 and 12 months, then annually through 5 years; Left atrial appendage (LAA) imaging at 4 months in the device group
- Non-inferiority
- Superiority
- 1:1 allocation
- Multicentre (142 global sites)
- Follow-up at 3 and 12 months, then annually through 5 years; LAA imaging at 4 months in the device group
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation. Am Heart J. Published 4 June 2023. doi:10.
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