AORTIC VALVE DISEASESVITTANCT06959836
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
An observational study of AORTIC VALVE DISEASES and Aortic Valve Stenosis and Insufficiency, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 3 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery
- What is being tested?
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 3 sitesBrazil
- Study dates
- 18 Mar 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent aortic or mitral valve replacement (native valve or bioprosthesis) with the VIVERE® Bovine Pericardial Bioprosthetic Valve.
Who may be able to join
- 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.
Who cannot join
- Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
- Contraindications specified in the IFUs.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital Nossa Senhora (Fundação Pio Xii)
Barretos, São Paulo, 14780-360
Hospital de Caridade São Vicente de Paulo
Jundiaí, São Paulo, 13201-625
Hospital Beneficência Portuguesa
São José do Rio Preto, São Paulo, 15015-750
About this study
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).
Read the 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.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation, Mitral Valve Surgery
- Being tested
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVERE Bovine Pericardial Bioprosthetic ValveDevice
Replacement of the native valve or bioprosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety performance
Procedure- or device-related mortality
Measured: 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.
Measured: 3 years post-implant
Secondary outcomes (6)
Clinical success
Defined as valve implantation without complications and without serious adverse events up to hospital discharge
Measured: Hospital discharge
Composite serious valve-related adverse events (non-linearized)
Defined as death, stroke, and/or reintervention within 3 years of valve implantation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days, 1 year, 2 years, and 3 years
All-Cause Mortality
Including cardiovascular and non-cardiovascular causes, within 3 years after implantation.
Measured: 3 years post-valve implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start18 Mar 2024
- Primary completion1 Feb 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AORTIC VALVE DISEASESStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959836
- Sponsor's protocol ID
- VITTA
- Acronym
- VITTA
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
- ClinicalTrials.gov ID
- NCT06959836
- Acronym / sponsor ID
- VITTA / VITTA
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation, Mitral Valve Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent aortic or mitral valve replacement (native valve or bioprosthesis) with the VIVERE® Bovine Pericardial Bioprosthetic Valve.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who received the VIVERE® Bovine Pericardial Bioprosthetic Valve for replacement of the tricuspid or pulmonary valve.
- Contraindications specified in the IFUs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVERE Bovine Pericardial Bioprosthetic ValveReplacement of the native valve or bioprosthesis | Device | – |
Primary outcome
Safety performance
Time frame: Hospital discharge or within 30 days of the procedure, whichever occurs first.
Procedure- or device-related mortality
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.
6 secondary outcomes
Clinical success
Time frame: Hospital discharge
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
Hemodynamic Performance
Time frame: From immediately after the intervention until study completion, with an average follow-up of 3 years
Structural Valve Deterioration
Time frame: 30 days, 1 year, 2 years, and 3 years
Serious Adverse Events (linearized rates)
Time frame: 30 days, 1 year, 2 years, and 3 years
All-Cause Mortality
Time frame: 3 years post-valve implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AORTIC VALVE DISEASES and Aortic Valve Stenosis and Insufficiency, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety performance (time frame: Hospital discharge or within 30 days of the procedure, whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.