Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
Trial Parameters
Brief Summary
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
Eligibility Criteria
Inclusion Criteria: * Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis * Age \>= 18 years * Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry. Exclusion Criteria: * Patient requires salvage surgery (according to EuroSCORE II definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia") * Not been able to provide informed consent