Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve

Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve

This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).

A multicenter, observational, retrospective, single-arm study. This study will include patients who underwent valve replacement (native or bioprosthetic) of the aortic or mitral valves using the VIVERE Bovine Pericardial Bioprosthetic Valve, between 2017 and 2022. Data will be collected up to 3 years post-procedure.

Inclusion Criteria:

• All patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the native valve or bioprosthesis in the aortic or mitral position, in accordance with the Instructions for Use (IFU).
• Patients aged > 18 years.

Exclusion Criteria:

• Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
• Contraindications specified in the IFUs.