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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVERE Bovine Pericardial Bioprosthetic Valve | Device | Replacement of the native valve or bioprosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Safety performance | Procedure- or device-related mortality | Hospital discharge or within 30 days of the procedure, whichever occurs first. |
| Efficacy outcome | Percentage of patients in NYHA (New York Heart Association functional classification) Class I or II at 3 years post-implant. | 3 years post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | Defined as valve implantation without complications and without serious adverse events up to hospital discharge | Hospital discharge |
| Composite serious valve-related adverse events (non-linearized) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent aortic or mitral valve replacement (native valve or bioprosthesis) with the VIVERE® Bovine Pericardial Bioprosthetic Valve.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nossa Senhora (Fundação Pio Xii) | Barretos | São Paulo | 14780-360 | Brazil | ||
| Hospital de Caridade São Vicente de Paulo |
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Defined as death, stroke, and/or reintervention within 3 years of valve implantation
| From immediately after the intervention until study completion, with an average follow-up of 3 years |
| Hemodynamic Performance | Effective orifice area (cm²), mean pressure gradient (mmHg) and paravalvular leak. | From immediately after the intervention until study completion, with an average follow-up of 3 years |
| Structural Valve Deterioration | Defined as calcification, fibrosis, and/or leaflet fracture. | 30 days, 1 year, 2 years, and 3 years |
| Serious Adverse Events (linearized rates) | 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. | 30 days, 1 year, 2 years, and 3 years |
| All-Cause Mortality | Including cardiovascular and non-cardiovascular causes, within 3 years after implantation. | 3 years post-valve implantation |
| Jundiaí |
| São Paulo |
| 13201-625 |
| Brazil |
| Hospital Beneficência Portuguesa | São José do Rio Preto | São Paulo | 15015-750 | Brazil |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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