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

What this Trial Is About

Researchers are comparing the blood flow and heart function effects of different types of aortic valve replacements and surgical techniques in patients with severe aortic valve stenosis, especially those with a small aortic annulus. The study aims to understand how various valve prostheses perform in lab tests and in patients, focusing on factors like pressure gradients, leaflet motion, and flow patterns to better guide treatment choices. It includes both surgical and less invasive transcatheter valve replacements, recognizing the challenges of avoiding complications and ensuring long-term valve durability. The study uses a special mock circulation system to test valves in the lab, including tissue, sutureless, mechanical, self-expandable, and balloon-expandable valves. It compares surgical implantation techniques like intra-annular and supra-annular positions and evaluates valve-in-valve procedures. After surgery, patients undergo transthoracic echocardiograms and 4D Flow MRI scans without contrast between 1 and 3 months post-procedure to measure valve function, blood flow, and pressure gradients. Participants will be monitored for about 1 to 3 months after their valve replacement surgery. Data collected include heart imaging results from echocardiograms and MRIs, blood pressure, heart rate, and blood tests. The study measures valve performance in the lab and in patients to validate findings. There are no expected direct benefits, but the information helps understand medium-term surgical outcomes. The total study duration is 24 months, involving careful imaging and clinical follow-up.

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