Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve

Braile Biomedica Ind. Com. e Repr. Ltda.150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

AORTIC VALVE DISEASES Aortic Valve Stenosis and Insufficiency Aortic Valve Surgery Mitral Valve Regurgitation Mitral Valve Surgery

Interventions

VIVERE Bovine Pericardial Bioprosthetic ValveDEVICE

Replacement of the native valve or bioprosthesis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Hospital Nossa Senhora (Fundação Pio Xii)

Barretos, São Paulo, Brazil

Hospital de Caridade São Vicente de Paulo

Jundiaí, São Paulo, Brazil

Hospital Beneficência Portuguesa

São José do Rio Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Safety performance

Procedure- or device-related mortality

Time frame: 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.

Time frame: 3 years post-implant

Secondary Outcomes

Clinical success

Defined as valve implantation without complications and without serious adverse events up to hospital discharge

Time frame: Hospital discharge

Composite serious valve-related adverse events (non-linearized)

Defined as death, stroke, and/or reintervention within 3 years of valve implantation

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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