Observational Study Collecting Real-World Outcomes of the INSPIRIS RESILIA Aortic Valve Replacement in Adults

What this Trial Is About

This observational registry study collects real-world data on the Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, in patients who need replacement of their native or prosthetic aortic valve as the only heart valve procedure. The study aims to monitor hemodynamic and clinical outcomes to better understand the valves performance in routine medical practice. Up to 500 subjects will be enrolled at up to 20 sites in Germany. Participants will receive the INSPIRIS RESILIA Aortic Valve through surgical replacement during their index procedure. The study records data from standard-of-care imaging evaluations such as echocardiography and CT scans before the valve replacement. There is no randomization or comparator group as this is an observational study focusing on patients treated with this specific valve. Participants heart function and valve performance will be assessed primarily by measuring average mean and peak gradients, and the amount of aortic transvalvular and paravalvular regurgitation. These measurements will be taken prior to discharge typically 7 to 10 days after surgery and at 3 months post-surgery. Additionally, patients New York Heart Association functional classification will be evaluated at baseline and after 3 months. The study involves standard clinical visits and imaging as part of routine care, with data collected for up to 3 months after valve implantation.

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve