Trials / Completed
CompletedNCT06959836
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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 VIVERE Bovine Pericardial Bioprosthetic Valve, between 2017 and 2022. Data will be collected up to 3 years post-procedure.
Conditions
- AORTIC VALVE DISEASES
- Aortic Valve Stenosis and Insufficiency
- Aortic Valve Surgery
- Mitral Valve Regurgitation
- Mitral Valve Surgery
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VIVERE Bovine Pericardial Bioprosthetic Valve | Replacement of the native valve or bioprosthesis |
Timeline
- Start date
- 2024-03-18
- Primary completion
- 2025-02-01
- Completion
- 2025-04-01
- First posted
- 2025-05-07
- Last updated
- 2025-05-07
Locations
3 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT06959836. Inclusion in this directory is not an endorsement.