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

Braile Biomedica

Status: Completed

Conditions: Mitral Valve Regurgitation; AORTIC VALVE DISEASES; Aortic Valve Surgery; Mitral Valve Surgery; Aortic Valve Stenosis and Insufficiency

Treatments: Device: VIVERE Bovine Pericardial Bioprosthetic Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT06959836

VITTA

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.