AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation, Mitral Valve Surgery
Conditions
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'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.
Interventions
DEVICEVIVERE Bovine Pericardial Bioprosthetic Valve
Replacement of the native valve or bioprosthesis
Sponsors
Braile Biomedica Ind. Com. e Repr. Ltda.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety performance | Hospital discharge or within 30 days of the procedure, whichever occurs first. | Procedure- or device-related mortality |
| Efficacy outcome | 3 years post-implant | Percentage of patients in NYHA (New York Heart Association functional classification) Class I or II at 3 years post-implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | Hospital discharge | Defined as valve implantation without complications and without serious adverse events up to hospital discharge |
| Composite serious valve-related adverse events (non-linearized) | From immediately after the intervention until study completion, with an average follow-up of 3 years | Defined as death, stroke, and/or reintervention within 3 years of valve implantation |
| Hemodynamic Performance | From immediately after the intervention until study completion, with an average follow-up of 3 years | Effective orifice area (cm²), mean pressure gradient (mmHg) and paravalvular leak. |
| Structural Valve Deterioration | 30 days, 1 year, 2 years, and 3 years | Defined as calcification, fibrosis, and/or leaflet fracture. |
| Serious Adverse Events (linearized rates) | 30 days, 1 year, 2 years, and 3 years | Bleeding, thromboembolism, valve thrombosis (thrombus formation with prosthetic dysfunction), endocarditis (infection leading to prosthetic dysfunction), non-structural valve dysfunction (leak, mismatch, and/or late embolization), and structural valve deterioration (calcification, fibrosis, and/or leaflet fracture), paravalvular leak, need for reintervention, and valve-related or non-valve-related death. |
| All-Cause Mortality | 3 years post-valve implantation | Including cardiovascular and non-cardiovascular causes, within 3 years after implantation. |
Countries
Brazil
Outcome results
None listed