Trials / Completed
CompletedNCT05902897
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Clinical Evaluation of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis -BIOPRO TRIAL
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 913 (actual)
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Detailed description
Multicenter, observational, retrospective, non-comparative, non-randomized study to determine the safety and clinical performance of the Bovine Pericardium Valvular Bioprosthesis in patients who required replacement of their native or bioprosthetic valve (aortic or mitral), according to ISO 14155 and ISO 5840.
Conditions
- Aortic Valve Insufficiency
- Aortic Valve Regurgitation
- Aortic Valve Stenosis
- Aortic Valve Incompetence
- Mitral Valve Insufficiency
- Mitral Valve Regurgitation
- Mitral Valve Stenosis
- Mitral Valve Incompetence
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis. | Heart Valve Replacement |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-07-01
- Completion
- 2023-10-30
- First posted
- 2023-06-15
- Last updated
- 2025-04-25
Locations
3 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05902897. Inclusion in this directory is not an endorsement.