Outcome Comparison of Different Surgical Strategies for the Management of Severe Aortic Valve Stenosis: Study Protocol of a Prospective Multicentre European Registry (E-AVR Registry)

What this Trial Is About

Researchers are gathering comprehensive data on severe aortic valve stenosis (SAVS) treatments, comparing traditional surgery, minimally invasive surgery, and transcatheter valve replacement in a real-world setting. This prospective European multicenter registry includes patients with SAVS, with or without coronary artery disease, to better understand outcomes beyond those seen in controlled trials. The study aims to clarify current treatment guidelines and provide insight into patient quality of life and heart function after surgery. The study includes all types of surgical aortic valve replacement procedures, such as mechanical and biological valves (sutured or sutureless), and surgical transcatheter approaches via different access points. Surgical techniques range from full sternotomy to minimally invasive thoracotomies. Patients are selected based on local heart team decisions and enrolled consecutively at 16 centers across six European countries. The recruitment lasts two years, followed by a long-term follow-up of at least five years and up to ten years. Participants undergo scheduled follow-ups at 30 days, 6 months, 1 year, and annually thereafter up to ten years to monitor outcomes. Data collected include mortality rates, cardiovascular events, valve complications, quality of life, echocardiographic results, and various postoperative complications. Data management ensures patient confidentiality and is monitored regularly for accuracy. This observational registry aims to provide robust, real-world evidence on the safety and outcomes of different SAVS surgical strategies.

Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)