Study of LIRA Sizing Method for Transcatheter Aortic Valve Replacement in Adults with Bicuspid Aortic Valve

What this Trial Is About

This research focuses on patients with raphe-type bicuspid aortic valve BAV who undergo transcatheter aortic valve replacement TAVR. The study aims to evaluate the effectiveness and safety of a new sizing method called the LIRA method, designed to improve prosthesis selection for these patients. BAV patients have unique anatomy that challenges treatment, and previous data shows risks like stroke and permanent pacemaker implantation remain significant despite newer devices. The study involves patients with severe aortic stenosis and type 1 or 2 BAV who receive TAVR using self-expanding supra-annular prostheses sized by the LIRA method. This sizing approach measures the perimeter at the raphe level, where valve anchoring occurs in BAV patients. The study observes outcomes after TAVR, including device success, adverse events, clinical efficacy, technical success, and valve performance. Participants are evaluated up to 30 days and one year after the TAVR procedure to monitor device success and related adverse events according to VARC 3 criteria. Clinical efficacy and valve performance are also assessed during follow-up. The study collects data on technical success at the procedures end and tracks any complications or outcomes related to the new sizing method, with the total study duration extending up to one year post-procedure.

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study