The safety and effectiveness of the MitraClip device to treat functional mitral regurgitation (FMR) has been tested in previous clinical trials yielding somewhat heterogeneous results in heart failure (HF) patients. Over time, the MitraClip device system has been modified and clinical practice evolved to consider also less severely diseased HF patients with FMR for this therapeutic option. The RESHAPE-HF2 trial aims to assess the safety and effectiveness of the MitraClip device system on top of medical therapy considered optimal in the treatment of clinically significant FMR in symptomatic patients with chronic HF.

中文翻译：

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MitraClip 装置治疗心力衰竭的随机研究：RESHAPE-HF2 试验设计的设计和原理


MitraClip 装置治疗功能性二尖瓣反流 (FMR) 的安全性和有效性已在之前的临床试验中得到测试，在心力衰竭 (HF) 患者中产生了有些异质的结果。随着时间的推移，MitraClip 装置系统得到了改进，临床实践也得到了发展，也考虑采用这种治疗方案来考虑病情较轻的 FMR 心力衰竭患者。 RESHAPE-HF2 试验旨在评估 MitraClip 装置系统在治疗有临床意义的慢性心力衰竭患者临床显着 FMR 的最佳药物治疗基础上的安全性和有效性。