Arrhythmias & electrophysiologyRandomised controlled trial
3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE)
- Randomised controlled trial
- multicentre
- 108 sites
Authors' conclusion
The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device.
Study context
- Population
- High-risk patients undergoing left atrial appendage occlusion
- Participants
- 1,878 patients · 108 sites
- Comparison
- Amulet vs Watchman 2.5 left atrial appendage occluder
Primary result
As reported in the abstract
Ischemic stroke or systemic embolism · 3 years
P = 0.69
Further findings
Free of OAC · 3 years
P < 0.01
All strokes, systemic embolism or CV death · 3 years
P = 0.31
All-cause death · 3 years
P = 0.08
CV death · 3 years
P = 0.14
Device factors (device-related thrombus or peridevice leak ≥3 mm) preceding ischemic stroke and cardiovascular (CV) death · 3 years
- More frequent with Watchman than Amulet
Safety
Major bleeding · 3 years
P = 0.46
Original publication
3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE). JACC Cardiovasc Interv. Published 14 August 2023. doi:10.1016/j.jcin.2023.06.022
Summarised from the published abstract; every number is checked against it