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Left atrial appendage closure with a novel nonpacifier device for stroke prevention in atrial fibrillation
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Left atrial appendage closure with a novel nonpacifier device for stroke prevention in atrial fibrillation
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Journal Article
Left atrial appendage closure with a novel nonpacifier device for stroke prevention in atrial fibrillation
2026
Overview
Percutaneous left atrial appendage (LAA) closure is a viable alternative to chronic oral anticoagulation for reducing thromboembolic risk in non-valvular atrial fibrillation (AF) patients. To date, no clinical data have been published on the novel nonpacifier LAA closure device evaluated herein. We therefore conducted a prospective, non-randomized, multi-center registry across 6 Chinese hospitals to provide the first clinical evidence of its safety and effectiveness among AF patients with an increased risk of stroke, using performance goals to assess 6-month effective LAA closure and 12-month ischemic stroke incidence. Among 187 enrolled patients (mean age 67.7 ± 7.5 years; mean CHA
2
DS
2
-VASc 4.0 ± 1.6; mean HAS-BLED 2.5 ± 1.1), device implantation succeeded in 184 (98.4%), with 4 (2.1%) major peri-procedural complications. Effective LAA closure was achieved in all (100%) patients at 6 months with a 1-sided 95% lower confidence interval (CI) of 98.0%. During the 12-month follow-up period, 1 of 176 patients (0.6%, 1-sided 95% upper CI 2.9%) experienced ischemic stroke, thus meeting both prespecified performance goals. The cumulative incidence of major clinical events was 11 of 176 patients (6.5%, 95% CI 2.9–10.1%). This novel LAA closure device is effective for stroke prevention in non-valvular AF, with high procedural success and low adverse events.
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ 692/4019
/ 692/699
/ Aged
/ Aspirin
/ Atrial Fibrillation - complications
/ Atrial Fibrillation - surgery
/ Ethics
/ Female
/ Humanities and Social Sciences
/ Humans
/ Ischemia
/ Left atrial appendage closure
/ Left Atrial Appendage Closure - adverse effects
/ Left Atrial Appendage Closure - instrumentation
/ Left Atrial Appendage Closure - methods
/ Male
/ Patients
/ Science
/ Stroke
