使用FireMagic TrueForce绝缘导管切除心房动的导管切除:TRUEFORCE试验
Rongfeng Zhang1, Huimin Chu2, Shaowen Liu3
1Department of Cardiology, Institute of Cardiovascular Diseases, First Affiliated Hospital of Dalian Medical University, Dalian, China.
Pacing and clinical electrophysiology : PACE
|June 19, 2023
概括
在FireMagic TrueForce导管对心房移除有希望,在最近的一项临床试验中实现了高成功率并证明了安全性.
科学领域:
- 心脏病学 心脏病学
- 电子生理学 电子生理学
- 医疗器械 医疗器械
背景情况:
- 接触力 (CF) 感应导管改善了对心房动 (AF) 的导管切除 (CA).
- 尽管有进展,但AF的CA成功率有限,并发症仍然存在.
研究的目的:
- 评估FireMagic TrueForce绝缘导管的临床可行性,有效性和安全性,用于患者进行AF的首次CA.
主要方法:
- 一项多中心,前性,单臂研究 (TRUEFORCE试验) 包括120名AF患者,他们使用FireMagic TrueForce导管接受CA.
- 肺静脉隔离 (PVI) 是主要的程序终点.
主要成果:
- 在100%的患者中实现了肺静脉隔离 (PVI).
- 在81.25%的患者中观察到没有复发性心房律乱.
- 没有报告严重的不良事件;轻微事件发生在3.33%的患者中.
结论:
- 对于AF的CA,FireMagic强度感应式废除导管在临床上是可行的.
- 导管表现出令人满意的短期和长期疗效和安全性.
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