Abstract
Background: Existing LAA occlusion devices are associated with limitations such as device-related thrombus (DRT) and peri-device leaks (PDL). This first-in-human feasibility study aimed to assess the preliminary safety and performance of the Zenith LAA Occlusion System.
Methods: The Zenith system features a nitinol-PET braided scaffold with full-face membrane coverage, an independent anchoring mechanism, and a handle system enabling precise deployment control. The two-stage deployment process allows repositioning before anchor delivery, enhancing procedural control. Device performance was evaluated by an independent core lab using 45-day transesophageal echocardiography (TOE), with successful LAA closure defined as a PDL of <3 mm.
Results: This phase 1 study enrolled 10 high-risk patients with nonvalvular AF (mean CHA2DS2-VASc score: 4.6 ± 0.3). Procedural success was achieved in 90% (9/10) of patients. One procedure was safely halted after intraprocedural assessment determined a larger device size was required, which was not yet available. At 45-day TOE, all 9 implanted devices were stable, and all subjects had successful LAA closure without DRT. No major device- or procedure-related adverse events were reported. Operators reported high satisfaction with the handle’s control, deployment ease, and anchor stability.
Conclusion: The FIH results suggest that the Zenith LAA Occlusion System is safe and effective, with its two-stage deployment and independent anchoring mechanism offering enhanced procedural control. Larger randomized studies and prolonged follow-up will be required to confirm these findings.