使用新系统:临床前评估和第一次在人体上的经验
Felix Mahfoud1, Christian Ukena2, Philip D Adamson3
1Department of Cardiology, University Heart Center, University Hospital Basel, Basel, Switzerland; Cardiovascular Research Institute Basel, University Heart Center, University Hospital Basel, Basel, Switzerland; Department of Biomedical Engineering, University Basel, Basel, Switzerland.
JACC. Cardiovascular interventions
|October 25, 2025
概括
在临床前和早期人类试验中,Zenith左心房附属体 (LAA) 阻塞系统在心房患者中预防中风方面显示出有前途的安全性和有效性. 这种新型设备实现了成功的植入和关闭,没有与设备相关的血栓,支持进一步的临床研究.
科学领域:
- 心血管医学 心血管医学
- 医疗器械 医疗器械
- 干预心脏病学 干预心脏病学
背景情况:
- 心房动 (AF) 具有显著的中风风险,大多数血块起源于左心房附属体 (LAA).
- 口服抗凝药是有效的,但不适合所有AF患者.
- 现有的皮LAA封闭装置面临着设备相关血栓 (DRT) 和周围设备泄漏等挑战.
研究的目的:
- 评估Zenith LAA封闭系统的安全性和性能.
- 评估包括临床前犬类模型和前性首次在人身上 (FIH) 研究.
主要方法:
- 一个多阶段评估涉及3个临床前犬类试验 (n=17) 和一个单臂前性FIH研究 (n=10) 在非膜性AF患者中.
- 泽尼斯系统具有可调整的Nitinol脚手架,PET膜,自闭管道和动态 anchoring系统.
- 主要随访包括45天的食道横断心电回声学.
主要成果:
- 临床前的探索性分析显示,在45天后,完全内皮化,没有DRT或显著炎症.
- 在FIH研究中,90%的患者 (9/10) 植入成功.
- 100%的患者 (9/9) 实现了初级安全性和性能终点,证明了急性手术成功,机械设备关闭,稳定植入物,并且在45天内没有DRT或严重不良事件.
结论:
- 在临床前和FIH评估中,Zenith LAA封闭系统在早期安全性和性能方面表现良好.
- 新的设计特点有助于有效的LAA密封和没有DRT.
- 结果支持在更大的临床试验中进一步调查Zenith系统.
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