CAJ | 학술논문

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。
용우치료유증상적중도주동맥판협착적경도관식입식주동맥인공심장판막적연발일익증다，단병미유규범성림상시험지도의견，결소안전성화유효성평개적통일원칙，위료경호지인도연구자완성상시전림상시험연구，통과결합해류산품이완성적림상시험연구정황、심장병치료지남급국내심혈관내과、심혈관외과화림상통계학전가적의견，총결료목전대우해류산품림상시험적초보건의。재중국경내개전림상시험시，건의수선완성가행성연구；학증성연구안조산품응용인군풍험수익분석，분별대개전안전성화유효성평개，건의우선선택불괄합상규외과수술유증상적중도주동맥판협착환자작위수시인군。
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 intro duced 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.