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

NCT06959836 | Completed

• 1 other identifier: VITTA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Clinical success

  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

• Hemodynamic Performance

  From immediately after the intervention until study completion, with an average follow-up of 3 years

• Structural Valve Deterioration

  30 days, 1 year, 2 years, and 3 years

• Serious Adverse Events (linearized rates)

  30 days, 1 year, 2 years, and 3 years

Interventions

VIVERE Bovine Pericardial Bioprosthetic Valve DEVICE

Replacement of the native valve or bioprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent aortic or mitral valve replacement (native valve or bioprosthesis) with the VIVERE® Bovine Pericardial Bioprosthetic Valve.

You may qualify if:

• 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.

You may not qualify if:

• Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
• Contraindications specified in the IFUs.

Sponsors & Collaborators

• Braile Biomedica Ind. Com. e Repr. Ltda.: lead

Study Sites (3)

Hospital Nossa Senhora (Fundação Pio Xii)

Barretos, São Paulo, 14780-360, Brazil

Location

Hospital de Caridade São Vicente de Paulo

Jundiaí, São Paulo, 13201-625, Brazil

Location

Hospital Beneficência Portuguesa

São José do Rio Preto, São Paulo, 15015-750, Brazil

Location

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 7, 2025
• Study Start: March 18, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)