Size Up Bicuspid with the LIra MEthod: the SUBLIME Study

Launched by IRCCS SAN RAFFAELE · Oct 23, 2024

Keywords

ClinConnect Summary

The SUBLIME Study is a clinical trial that is looking at a new way to size heart valves for patients with a specific type of heart condition called a raphe-type bicuspid aortic valve (BAV). This condition can make it difficult for blood to flow properly, and the standard treatment involves replacing the affected valve using a procedure called transcatheter aortic valve replacement (TAVR). The goal of this study is to see if the LIRA sizing method can improve the outcomes of TAVR, such as reducing the risk of complications like stroke or the need for a pacemaker.

To participate in this study, you need to be at least 18 years old and have severe narrowing of the aortic valve due to a type 1 or 2 BAV. The trial is currently recruiting patients, and it runs from September 2018 to June 2024. If you join, you will receive a self-expanding heart valve that is sized using the LIRA method during your TAVR procedure. This study aims to provide important information that could help improve treatment for others with similar heart conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024
• Exclusion Criteria:
• • Redo-TAVR
• • TAVR performed in emergency setting
• • TAVR performed for severe aortic regurgitation