Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

What this Trial Is About

Researchers are investigating valve performance after valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) in patients with surgical aortic bioprosthetic valve failure. The study focuses on comparing hemodynamic optimization using Doppler-echocardiography versus cardiac catheterization measurements. This trial aims to clarify differences in valve gradient assessments and better understand procedural-device failure rates reported in previous ViV-TAVR studies. The study involves patients with stented surgical bioprosthetic valves sized 25 mm or smaller who are scheduled for a ViV-TAVR procedure using the SAPIEN 3 Ultra valve or its newer versions. After valve implantation, participants are randomly assigned to have further interventions guided either by Doppler-echocardiographic measurements or by invasive hemodynamic measurements, including simultaneous aortic and ventricular pressure recordings. If a residual mean gradient of 20 mmHg or more is found by the assigned measurement method, balloon post-dilation with a non-compliant balloon will be performed. Participants will be followed for up to five years with evaluations at 1 month, 12 months, and yearly thereafter. Assessments include quality of life, periprocedural complications, residual transvalvular gradient, valve performance measures such as prosthesis-patient mismatch and aortic regurgitation, heart failure status, exercise capacity, structural valve degeneration indicators, and need for valve re-intervention. Safety and clinical outcomes will be monitored regularly, including rehospitalizations and changes in left ventricle mass.

Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR