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<p>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.&#xa0;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&#xa0;years; mean CHA<sub>2</sub>DS<sub>2</sub>-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&#xa0;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.</p>

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Left atrial appendage closure with a novel nonpacifier device for stroke prevention in atrial fibrillation

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月12日

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  • Ziyong Hao,
  • Weifeng Zhang,
  • Zhongping Ning,
  • Chenyang Jiang,
  • Lihong Wang,
  • Jianjun Jiang,
  • Heng Zhang,
  • Cheng Wang,
  • Xin Pan,
  • Lisheng Jiang,
  • Ben He

摘要

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 CHA2DS2-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.