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Completed

NCT Number: NCT06959836

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

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).

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Key information

Conditions

AORTIC VALVE DISEASES Aortic Valve Disease Aortic Valve Stenosis Aortic Valve Stenosis and Insufficiency Aortic Valve Surgery Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Surgery Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Nossa Senhora (Fundação Pio Xii), Barretos, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIVERE Bovine Pericardial Bioprosthetic Valve

Device

Replacement of the native valve or bioprosthesis

Primary outcomes

  1. Safety performance

    Time frame: Hospital discharge or within 30 days of the procedure, whichever occurs first.

    Procedure- or device-related mortality

  2. Efficacy outcome

    Time frame: 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 outcomes

  1. Clinical success

    Time frame: Hospital discharge

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

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

    Time frame: 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

  3. Hemodynamic Performance

    Time frame: 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.

  4. Structural Valve Deterioration

    Time frame: 30 days, 1 year, 2 years, and 3 years

    Defined as calcification, fibrosis, and/or leaflet fracture.

  5. Serious Adverse Events (linearized rates)

    Time frame: 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.

  6. All-Cause Mortality

    Time frame: 3 years post-valve implantation

    Including cardiovascular and non-cardiovascular causes, within 3 years after implantation.

Sponsors and collaborators

Lead sponsor

Braile Biomedica Ind. Com. e Repr. Ltda.

Industry

Registry information

Acronym: VITTA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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