[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

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Source: The Lancet

Original: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02215-9/fullt...

Published: 2025-11-16T13:30:01Z

The ALIGN-AR trial was multicenter, single-arm, and focused on patients with symptomatic moderate to severe native aortic regurgitation who were at high surgical risk. She used a specially designed Trilogy transcatheter aortic valve. The results showed that this approach met the pre-specified safety and efficacy goals. Patients experienced a significant reduction in aortic regurgitation, favorable valve hemodynamics, and myocardial remodeling. Their functional status and quality of life also improved, up to 2 years of follow-up. The success rate of implantation was over 95% in a group of 500 patients. These data support the use of the Trilogy valve as a safe and effective alternative for patients with native aortic regurgitation who are too high risk for surgical valve replacement. Paravalvular regurgitation decreased from 8.2% at one year to 4.4% at two years. Hemodynamic parameters remained stable during the observed period[1][2][5][6].