The LANCET:Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study Volume 406, Issue 10521P2757-2771December 13, 2025

This study, known as ALIGN-AR, investigated the use of the Trilogy valve, a device specifically engineered for native aortic regurgitation (AR), a condition where older devices optimized for calcific aortic stenosis were not suitable. The research followed high surgical risk patients with symptomatic moderate-to-severe or severe AR undergoing a transcatheter aortic valve intervention (TAVI) to assess the procedure's safety, valve function, and clinical outcomes. The trial successfully met its pre-specified safety composite and all-cause mortality performance goals, demonstrating that TAVI with this purpose-built device is a feasible and effective treatment option for selected high-risk patients by improving functional status and reducing AR.