Status:
COMPLETED
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
Lead Sponsor:
Braile Biomedica Ind. Com. e Repr. Ltda.
Conditions:
AORTIC VALVE DISEASES
Aortic Valve Stenosis and Insufficiency
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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 VIVER...
Eligibility Criteria
Inclusion
- 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
- Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
- Contraindications specified in the IFUs.
Key Trial Info
Start Date :
March 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06959836
Start Date
March 18 2024
End Date
April 1 2025
Last Update
May 7 2025
Active Locations (3)
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1
Hospital Nossa Senhora (Fundação Pio Xii)
Barretos, São Paulo, Brazil, 14780-360
2
Hospital de Caridade São Vicente de Paulo
Jundiaí, São Paulo, Brazil, 13201-625
3
Hospital Beneficência Portuguesa
São José do Rio Preto, São Paulo, Brazil, 15015-750