Arrhythmias & electrophysiology
Transcatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device
Authors' conclusion
The preclinical and early clinical results demonstrate a promising safety and efficacy profile for the Laminar LAA exclusion device.
Study context
- Population
- Healthy canines and humans with nonvalvular AF at risk of ischemic stroke and systemic thromboembolism
- Participants
- 10 vs 15
- Comparison
- Canines vs Human
- Caninesn = 10
- Humann = 15
- Outcome
- Procedural success (device implantation in intended location without residual LAA leak >5 mm by TEE); safety: freedom from stroke, systemic embolism, pericardial effusion or tamponade, life-threatening/major bleeding, or death
- Follow-up
- 12 months postimplantation
Methodological detailssingle-group
- Single-group
Main finding
As reported in the abstract
| Group | Value | Peridevice leak (PDL) or device-related thrombus (DRT) at 45 and 150 days |
|---|---|---|
| Canines | 10 events | 0 |
| Human | 15 events |
Value
Canines10 events
Human15 events
Peridevice leak (PDL) or device-related thrombus (DRT) at 45 and 150 days
Canines0
Human— not stated in the abstract
Safety
- Safety events (human subjects) · 12 months postimplantation
- 0 · events
Original publication
Transcatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device. JACC Cardiovasc Interv. Published 7 June 2023. doi:10.
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