经导管植入式主动脉人工心脏瓣膜临床试验初步建议

Considerations on Clinical Study of Transcatheter Aortic Valve Implantation

用于治疗有症状的重度主动脉瓣狭窄的经导管植入式主动脉人工心脏瓣膜的研发日益增多,但并未有规范性临床试验指导意见,缺少安全性和有效性评价的统一原则,为了更好地引导研究者完成上市前临床试验研究,通过结合该类产品已完成的临床试验研究情况、心脏病治疗指南及国内心血管内科、心血管外科和临床统计学专家的意见,总结了目前对于该类产品临床试验的初步建议。在中国境内开展临床试验时,建议首先完成可行性研究;确证性研究按照产品应用人群风险收益分析,分别对开展安全性和有效性评价,建议优先选择不适合常规外科手术有症状的重度主动脉瓣狭窄患者作为受试人群。

Transcatheter aortic valve implantation for the patients suffering from severe aortic stenosis has emerged as a promising technique alternative to conventional surgical aortic valve replacement, the guidances of clinical study to evaluate the safety and efficacy of the products have not been drafted as so far. The recommendations which were drafted according to the existing clinical data and guideline for valvular heart disease and expert advice were introduced in the article in order to provide a guidance to manufacturers. Feasibility study to see if a larger pivotal study is practical and to refine the study protocol for the pivotal study was recommended firstly, the hypothesis of pivotal study was built in accordance with benefit-risk analysis, the aortic stenosis patients who cannot undergo surgery was preferen- tially treated in clinical trial.