Avalus European Registry - Observational Study Evaluating Safety and Efficacy of Surgical Aortic Valve Replacement with Avalus Bioprosthetic Valve

What this Trial Is About

Researchers are conducting a prospective, observational, single-arm, multi-center registry to study patients undergoing surgical aortic valve replacement using the Avalus pericardial bioprosthetic valve. The goal is to assess the real-world outcomes and performance of this specific bioprosthetic valve in treating conditions such as aortic valve stenosis and insufficiency. The study aims to gather clinical and hemodynamic data from about 1000 patients across multiple sites in Europe and possibly Canada. Participants will undergo bioprosthetic aortic valve replacement with the Avalus valve. This registry does not involve any experimental treatments but collects data to evaluate the safety and performance of the Avalus valve as it is used in normal clinical practice. The study includes only a single group of patients receiving this valve and excludes those undergoing salvage surgeries or younger than 18 years. Outcomes are evaluated up to one year after surgery using standard criteria. During the study, participants' health will be monitored through clinical assessments following their valve replacement procedure. Researchers will collect data on major outcomes, including a composite measure of all-cause mortality and disabling stroke one year after surgery, as well as secondary evaluations according to VARC-2 criteria. The study involves follow-up visits and data collection for one year postoperatively to track the valve's performance and patient safety.

Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population