CompletedNot Applicable

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

Brazil150 participantsStarted 2024-03-18

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Safety performance

Timeframe: Hospital discharge or within 30 days of the procedure, whichever occurs first.

Efficacy outcome

Timeframe: 3 years post-implant

Trial details

NCT IDNCT06959836

SponsorBraile Biomedica Ind. Com. e Repr. Ltda.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-01

View on ClinicalTrials.gov More AORTIC VALVE DISEASES trials