Valvular & structural heart diseaseRandomised controlled trial
3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation
- Randomised controlled trial
- investigator-initiated
- multicentre (8 centres)
- 3 patients randomised to Amulet received Watchman FLX
- 3-year follow-up rate 96.4% (Amulet) and 97.3% (Watchman)
Authors' conclusion
At 3 years after LAAC, there was no significant difference in the ischemic risk between the Amulet and the Watchman FLX groups.
Study context
- Population
- Patients with AF and high bleeding risk undergoing left atrial appendage closure (LAAC)220 completed LAAC
- Participants
- 221 patients
- Comparison
- Amulet vs Watchman FLX for percutaneous LAAC
- Primary endpoint
- Composite of:
- CV death
- Stroke
- TIA
- Systemic embolism
- Follow-up
- 3 years
Primary result
Composite ischemic endpoint
Hazard ratio
0.58
95% CI 0.33–1.03
P = 0.06
By group
Amulet vs Watchman
HR 0.58 (95% CI 0.33–1.03); P = 0.06
As reported in the abstract
Further findings
| Outcome | Amulet | Watchman | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Composite ischemic endpoint, as-treated population · 3 years · as-treated | 17.0% | 31.1% | 0.53 (0.30–0.96) | P = 0.035 | |
| Composite ischemic endpoint, per-protocol population · 3 years · per-protocol | 16.2% | 29.2% | 0.54 (0.29–1.00) | P = 0.049 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation. J Am Coll Cardiol. Published 8 July 2025. doi:10.1016/j.jacc.2025.03.535
Summarised from the published abstract; every number is checked against it