经导管植入式主动脉人工心脏瓣膜临床试验初步建议.pdfVIP

中国药物警戒第11卷第10期 2014年10月 October,2014,Vol.11,No.10 中图分类号：R197.39 文献标识码：A 文章编号：1672-8629（2014 ）10-0628-04 经导管植入式主动脉人工心脏瓣膜临床试验初步建议 程茂波 史新立 苗晶晶 刘威 聂飞龙 （国家食品药品监督管理总局医疗器械技术审评中心，北京100044） 摘要：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。 关键词：经导管植入式主动脉人工心脏瓣膜；临床试验；可行性研究；确证性研究 Considerations on Clinical Study of Transcatheter Aortic Valve Implantation CHENG Mao-bo SHI Xin-li MIAO Jing-jing LIU Wei NIE Fei-long (Center for Medical Device Evaluation, CFDA, Beijing 100044, China) Abstract: 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. Key words: transcatheter aortic valve implantation; clinical trial; feasibility study; pivotal study 约有1/3的主动脉瓣狭窄患者由于各种因素如钙化、 展临床试验研究，如美国爱德华公司的Sapien系列瓣膜 严重共患疾病等导致外科手术风险较高而不能进行瓣膜 和美敦力公司的CoreValve系列瓣膜。从表1[5-7]中可以