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 preferentially treated in clinical trial.

Key words: transcatheter aortic valve implantation, clinical trial, feasibility study, pivotal study