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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT05572710

S63824

Details and patient eligibility

About

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.

Full description

The study is a prospective, observational, single-arm, multi-center registry. The patients must 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.

The goal of this project is to evaluate the real world results of aortic valve replacement with the Avalus valve. This will result in clinical and hemodynamic knowledge of this particular valve. The investigators are aiming for 1000 patient inclusions distributed over 40 sites across Europe and potentially also involving Canada.

Intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. Patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. Outcome is evaluated in accordance with the VARC-2 criteria up to 1-year postoperatively.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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