双室无心脏起器的一年安全性和性能
Reinoud E Knops1, James E Ip2, Rahul Doshi3
1Amsterdam UMC, the Netherlands (R.E.K., K.T.N.B.).
Circulation. Arrhythmia and electrophysiology
|March 27, 2025
概括
这项研究表明,双室无心脏起器是安全和有效的心治疗,高无并发症和性能成功率持续到12个月.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 临床试验 临床试验
背景情况:
- 无心脏起器提供了传统起器的替代品,用于心治疗.
- 通过无技术,可以避免与导线和脉冲发生器相关的并发症.
研究的目的:
- 评估12个月后双室无心脏起器的持续安全性和性能.
- 为了确定12个月的结果是否符合预先规定的目标,以实现无并发症和表现成功.
主要方法:
- 展望性,单组研究 (Aveir DR i2i研究) 招募具有标准双室节奏指示的患者.
- 植入Aveir DR双室无心脏起器系统 (右心房和右心室).
- 评估12个月后的主要安全性 (无严重设备/程序事件) 和性能 (心房捕获值和传感幅度) 终点.
主要成果:
- 实现了主要安全终点,12个月无并发症率为88.6%.
- 主要性能终点在92.8%的患者中实现.
- 在300名受试者中尝试了植入,鼻结功能障碍和心房阻塞是主要迹象.
结论:
- 双室无心脏起器在1年内实现了主要的安全性和性能目标.
- 这些12个月的结果与之前报告的3个月的结果一致.
- 这项研究证实了无双室节奏器的持续有效性和安全性.
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