Comparing Down Sizing and Standard Sizing Strategies for Transcatheter Aortic Valve Replacement in Patients with Type 0 Bicuspid Aortic Stenosis

What this Trial Is About

Researchers are comparing two sizing strategies for transcatheter aortic valve replacement TAVR in patients with severe bicuspid aortic stenosis type 0. This study aims to evaluate the down sizing strategy versus the standard annular sizing strategy using self-expanding valves. Bicuspid aortic valve patients undergoing TAVR face higher risks such as perivalvular leakage and device failure, especially with heavily calcified valve leaflets common in this group. The study involves two groups an experimental group using a balloon-based down sizing approach where the valve size is smaller than the annular sizing recommendation, and a control group using the traditional annular sizing method. Both groups use Evolut PRO self-expanding valves with pre-dilation balloon sizing just below the annular size. The implant depth target is 0-3 mm for both groups. Balloon sizing assists in determining the presence of a waist sign to guide valve size selection in the experimental group. Participants will undergo TAVR procedures with detailed follow-up assessments including clinical event rates of device success, pacemaker implantation, and new left bundle branch block occurrence measured at 1 month after the procedure. Safety and device performance are monitored closely with evaluations of valve function and complications. The trial is randomized, double-blind, and will continue until June 2030, with all visits and outcomes carefully recorded.

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)