Testing and Comparing Heart Valve Prostheses for Aortic Stenosis with Small Annulus Using Laboratory and Patient Imaging

What this Trial Is About

This research aims to compare the blood flow performance of different types of aortic valve prostheses and surgical implantation methods. It focuses on patients with severe aortic valve stenosis, particularly those with small aortic annulus, a condition common in people over 65 years old. The study combines in vitro testing using a specially designed mock circulation system with in vivo validation in patients, to better understand valve function and potential complications related to blood flow and valve design. Participants receive various types of surgical or transcatheter aortic valve replacements, including tissue valves, suturelessrapid deployment valves, and mechanical valves, with implantation techniques such as intra-annular or supra-annular positioning. The study involves advanced imaging and measurement techniques like 4D Flow MRI and transthoracic echocardiography to evaluate valve performance and blood flow patterns. Testing occurs both in the lab and in patients between 1 and 3 months after their valve replacement surgery. During the study, participants undergo standard clinical tests including transthoracic echocardiography and MRI scans without contrast to monitor valve function. Researchers collect detailed data on valve structure, blood flow, pressure gradients, and valve motion to assess performance and potential risks such as valve deterioration or blood flow disturbances. The total follow-up lasts about 1 to 3 months after surgery, aiming to provide insights to guide treatment decisions for patients with aortic stenosis.

In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation