Arrhythmias & electrophysiology
Left Atrial Appendage Occlusion Using a Novel System: Preclinical Evaluation and First-in-Human Experience
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
Methodological detailssingle-arm, prospective, 3 preclinical canine trials
- Single-arm
- Prospective
- 3 preclinical canine trials
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
- No device- or procedure-related serious adverse events occurred
Original publication
Left Atrial Appendage Occlusion Using a Novel System: Preclinical Evaluation and First-in-Human Experience. JACC Cardiovasc Interv. Published 25 October 2025. doi:10.
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