Arrhythmias & electrophysiologyCohort study
Left Atrial Appendage Occlusion Using a Novel System
- First-in-human study with preclinical evaluation
- single-arm
- prospective
- 3 preclinical canine trials
Authors' conclusion
This novel LAA occlusion system demonstrated favorable early safety and performance in both preclinical and FIH evaluation.
Study context
- Population
- Nonvalvular AF patients; preclinical canine modelsplus 17 canines
- Participants
- 10 patients
- Outcome
- Safety: acute procedural success; performance: mechanical device closure
- Follow-up
- 45 days
Main finding
As reported in the abstract
Acute procedural success (primary safety endpoint); mechanical device closure (primary performance endpoint)
Acute procedural success (a priori primary safety endpoint)
9 of 9 patients (100%)
Mechanical device closure at 45 days (a priori primary performance endpoint)
9 of 9 patients (100%)
Observational data: associations, not effects.
Further findings
Successful implantation (first-in-human (FIH))
- Successful implantation
- 9 of 10 patients (90%)
45-day TEE
- All implants stable, complete protocol-defined left atrial appendage (LAA) closure and no device-related thrombus (DRT)
Preclinical canine explant analysis · 45 days
- Complete endothelialization, no DRT or significant inflammation (n = 17 canines)
Safety
Device- or procedure-related serious adverse events
- No device- or procedure-related serious adverse events occurred
Original publication
Left Atrial Appendage Occlusion Using a Novel System. JACC Cardiovasc Interv. Published 25 October 2025. doi:10.1016/j.jcin.2025.10.002
Summarised from the published abstract; every number is checked against it