[Articles] Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study

In patients with symptomatic moderate-to-severe or severe aortic regurgitation considered to be of high surgical risk, TAVI with a dedicated platform met prespecified safety and effectiveness performance goals. We observed substantial reductions in aortic regurgitation, favourable valve haemodynamics and myocardial remodelling, with associated improvements in functional status and quality-of-life gains up to 2 years. These data support TAVI with a purpose-built device as a feasible and effective treatment option for selected patients with native aortic regurgitation who are at high risk for death or complications after surgery.