美国心脏植入型电子器械上市前临床研究回顾

Review of Pre-market Clinical Trials for Cardiac Implantable Electronic Devices in the United States

本文简要回顾了美国食品药品监督管理局批准的波士顿科学、美敦力及圣犹达这3家全球最大的心脏植入型电子器械公司相关产品的上市前临床研究,重点关注了研究设计、终点选择及样本量,希望能对国内开展相应的工作提供参考。

We reviewed the pre-market clinical trials for cardiac implantable electronic devices in the United States manufactured by the three largest companies:Boston Scientific,Medtronic and St.Jude Medical.The review focused on clinical trial design,study endpoints and sample size,which would provide reference to similar endeavors in China.