Arrhythmias & electrophysiology
Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial
Authors' conclusion
High-risk DRTs were observed in a higher number of Watchman 2.5 device patients compared with Amulet occluder patients. The composite of stroke, systemic embolism, or cardiovascular death occurred more often in patients with high-risk DRTs compared with those with low-risk DRTs or no DRTs. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [Amulet IDE Trial]; NCT02879448).
Study context
- Population
- Patients with a successful left atrial appendage occlusion device implant (Amulet or Watchman 2.5)patients with a successful device implant
- Participants
- 1,788 patients
- Comparison
- High-risk device-related thrombus (DRT) group compared with the low-risk DRT or no-DRT group; Watchman 2.5 device compared with the Amulet occluder
- Amuletn = 903
- Watchman 2.5n = 885
- Outcome
- DRT
- Follow-up
- Throughout 12 months
Methodological detailsAMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial, independent core laboratory, clinical events through 5 years
- AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial
- Independent core laboratory
- Clinical events through 5 years
Main finding
As reported in the abstract
Further findings
| Outcome | Amulet | Watchman 2.5 | High-risk DRT | Low-risk DRT or no-DRT | HR (95% CI) | P value | |
|---|---|---|---|---|---|---|---|
| Composite of stroke, systemic embolism, or cardiovascular death · Through 5 yearsHigh-risk DRTvs low-risk DRT or no-DRT | — not stated in the abstract | — not stated in the abstract | 30.4% | 19.9% | 1.74 (1.03–2.92) | P = 0.037 | |
| Cardiovascular death · Through 5 yearsHigh-risk DRTvs low-risk DRT or no-DRT | — not stated in the abstract | — not stated in the abstract | 26.4% | 14.5% | 2.09 (1.20–3.66) | P = 0.009 | |
| 0.20.5125Hazard ratio (log scale) |
— not stated in the abstract
| Outcome | Amulet | Watchman 2.5 | High-risk DRT | Low-risk DRT or no-DRT |
|---|---|---|---|---|
| High-risk DRT | 2.2% | 4.0% | — not stated in the abstract | — not stated in the abstract |
— not stated in the abstract
- High-risk DRT: P = 0.030
DRT resolution
- Low-risk DRTs resolved
- 12 of 15
- High-risk DRTs unresolved
- 34 of 55
All clinical outcome rates · Through 5 years
- Numerically higher in the high-risk DRT group compared with the low-risk DRT or no-DRT group
Original publication
Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial. JACC Clin Electrophysiol. Published 9 April 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →