Arrhythmias & electrophysiologyRandomised controlled trial
Left atrial appendage closure with the AnchorMan or Watchman devices: 12-month results of the SAFE-PROTECT randomised trial
- multicentre, open-label, non-inferiority trial
- randomised 1:1
Authors' conclusion
Among patients with non-valvular AF at high risk of ischaemic stroke, the AnchorMan device met its prespecified non-inferiority primary clinical success and secondary LAA occlusion endpoints compared with the Watchman 2.5 device.
Study context
- Population
- Patients with non-valvular atrial fibrillation (AF) at high risk of ischaemic strokerandomised
- Participants
- 216 patients
- Comparison
- AnchorMan compared with the Watchman 2.5 device
- AnchorMann = 108
- Watchmann = 108
- Primary endpoint
- Clinical success (freedom from ischaemic/haemorrhagic stroke, systemic embolism, cardiovascular or unexplained death)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Difference
−0.3
95% CI −3.9 to 3.5
P > 0.99
By group
AnchorMan vs Watchman
difference −0.3 (95% CI −3.9 to 3.5); P > 0.99
Secondary outcomes
| Outcome | AnchorMan | Watchman | difference (95% CI) | |
|---|---|---|---|---|
| Echocardiography-defined LAA occlusion (peridevice leak <5 mm) (powered secondary efficacy endpoint) · 12 months · pnon-inferiority=not applicable | 100% | 100% | 0% (−3.60 to 3.50) | |
| −4−2024Difference (linear scale) |
Original publication
Left atrial appendage closure with the AnchorMan or Watchman devices: 12-month results of the SAFE-PROTECT randomised trial. EuroIntervention. Published 6 July 2026. doi:10.4244/eij-d-25-01168
Summarised from the published abstract; every number is checked against it