Study Comparing Safety and Effectiveness of Surgical Aortic Valve Replacement Versus Transcatheter Valve Replacement in Low-Risk Patients with Severe Aortic Stenosis

What this Trial Is About

Researchers are evaluating surgical aortic valve replacement SAVR compared to transcatheter aortic valve replacement TAVR in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This study, called the AMETHYST trial, aims to determine if SAVR is not worse than TAVR regarding death, stroke, and rehospitalization one year after the procedure. The study is randomized, controlled, and conducted at multiple centers. Participants will be randomly assigned to either receive SAVR, where the surgeon chooses the type of surgical bioprosthetic valve and surgical method, or TAVR, which uses approved transcatheter heart valves available in Japan. The treatments will be delivered according to the assigned group, and patients will be followed for up to 10 years with visits at discharge, 30 days, and annually. During the study, participants will undergo assessments including survival, stroke occurrence, rehospitalization related to valve or heart failure, and heart rhythm changes. Researchers will also evaluate valve function using echocardiography and quality of life through questionnaires at one year. Safety monitoring continues through the long follow-up period. The primary outcome combines death from any cause, stroke, and rehospitalization at one year post-procedure.

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients