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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 5, 2022

Keywords

ClinConnect Summary

The Avalus European Registry is a clinical study that looks at how safe and effective the Avalus bioprosthetic valve is for patients with heart conditions such as aortic valve stenosis or insufficiency. This study is observing patients who are having surgery to replace their aortic valve with this specific valve to see how well it works in real-life situations. The trial is currently recruiting participants who are 18 years or older and have been advised by their doctor that they need a valve replacement.

To take part in this study, patients must be able to provide consent and understand the risks involved, although the risks are considered low because the Avalus valve is already in regular use. Patients who require emergency surgery or cannot give consent will not be eligible. Those who participate can expect to have their outcomes monitored after the surgery, helping researchers gather important information about the valve's performance and safety over time.

Gender

ALL

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