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

NCT06959836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-05-07

No results posted yet for this study

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).

Conditions

  • AORTIC VALVE DISEASES
  • Aortic Valve Stenosis and Insufficiency
  • Aortic Valve Surgery
  • Mitral Valve Regurgitation
  • Mitral Valve Surgery

Interventions

DEVICE

VIVERE Bovine Pericardial Bioprosthetic Valve

Replacement of the native valve or bioprosthesis

Sponsors & Collaborators

  • Braile Biomedica Ind. Com. e Repr. Ltda.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2025-02-01
Completion
2025-04-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959836 on ClinicalTrials.gov