Aortic Valve InsufficiencyNCT05902897

Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis

An observational study of Aortic Valve Insufficiency and Aortic Valve Regurgitation, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis
What is being tested?: Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
Type of treatment: Medical device
How many people: 913 participants
Where: 3 sitesBrazil
Study dates: 1 Jan 2023to 30 Oct 2023
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 undergoing valve replacement (aortic or mitral) with Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis, from 2013 to 2021.

Who may be able to join

(Group I - Aortic):
Symptomatic patients with severe aortic insufficiency.
Asymptomatic patients with severe aortic insufficiency and left ventricular ejection fraction (LVEF) at rest ≤ 50%.
Patients with severe aortic insufficiency and undergoing coronary artery bypass graft surgery (CABG) or surgery of the ascending aorta or other valve.
Asymptomatic patients with severe aortic insufficiency and resting ejection fraction > 50% with severe left ventricular (LV) dilation: left ventricular end-diastolic diameter (LVDD) > 70 mm or left ventricular ejection fraction (LVEF) > 50 mm (or LVEF > 25 mm/m2 of body surface, in patients with small body size).
Symptomatic patients with severe high gradient aortic stenosis (mean gradient ≥ 40 mmHg or peak velocity ≥ 4.0 m/s).

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Symptomatic patients with severe low-flow, low-gradient aortic stenosis (< 40 mmHg) with reduced ejection fraction and evidence of flow reserve (contractile) excluding pseudo-severe aortic stenosis.
Symptomatic patients with low-flow, low-gradient (< 40 mmHg) aortic stenosis with normal ejection fraction after careful confirmation of severe aortic stenosis.
Symptomatic patients with low-flow, low-gradient aortic stenosis and reduced ejection fraction without flow reserve (contractile), particularly when the amount of calcium on computed tomography (CT) confirms severe aortic stenosis.
Patients with symptomatic aortic stenosis at low surgical risk (STS or EuroSCORE II < 4% or logistic EuroSCORE I < 10% and no other risk factors not included in these scores, such as fragility, porcelain aorta, sequelae of thoracic radiation).
Asymptomatic patients with severe aortic stenosis and LV systolic dysfunction (LVEF < 50%) not due to another cause.
Asymptomatic patients with severe aortic stenosis and an abnormal exercise test showing exercise symptoms clearly related to aortic stenosis.
Asymptomatic patients with severe aortic stenosis and an abnormal exercise test showing a decrease in blood pressure below baseline.
Asymptomatic patients with normal ejection fraction and no exercise stress test abnormality, if the surgical risk is low and have very severe aortic stenosis defined by a peak transvalvular velocity (Vmax) > 5.5 m/s.
Asymptomatic patients with normal ejection fraction and no exercise test abnormality, if the surgical risk is low and severe valve calcification and Vmax progression rate ≥ 0.3 m/s/year.
Asymptomatic patients with normal ejection fraction and no exercise stress test abnormality, if surgical risk is low and B-type natriuretic peptide (BNP) marker levels are high.
Asymptomatic patients with normal ejection fraction and no change in the exercise test, if the surgical risk is low and severe pulmonary hypertension (pulmonary artery systolic arterial pressure at rest > 60 mmHg confirmed by invasive measurement) with no other explanation.
Patients with severe aortic stenosis undergoing CABG or surgery of the ascending aorta or other valve.
Patients with moderate aortic stenosis undergoing CABG or surgery of the ascending aorta or other valve after decision by the Heart Team.
7.2. Inclusion Criteria (Group II - Mitral):
Symptomatic patients with severe primary mitral insufficiency and LVEF > 30%.
Asymptomatic patients with severe primary mitral insufficiency and LV dysfunction (LVEF > 45 mm and/or LVEF < 60%).
Asymptomatic patients with severe primary mitral regurgitation and preserved LV function (LVEF < 45 mm and LVEF > 60%) and atrial fibrillation secondary to mitral regurgitation or pulmonary hypertension (rest systolic pulmonary pressure > 50 mmHg).
Asymptomatic patients with severe primary mitral regurgitation and preserved LVEF (> 60%) and LVEF 40-44 mm, with leaflet failure.
Asymptomatic patients with severe primary mitral regurgitation and preserved LVEF (> 60%) and LVEF 40-44 mm, and presence of significant LA dilation (volume index ≥ 60 mL/m2 of body surface) in sinus rhythm.
Patients with severe primary mitral regurgitation and severe LV dysfunction (LVEF < 30% and/or LVEF > 55 mm) refractory to medical therapy.
Patients with severe chronic secondary mitral regurgitation undergoing CABG and LVEF > 30%.
Symptomatic patients with severe secondary mitral regurgitation, LVEF < 30%, but with the option of revascularization and evidence of myocardial viability.
Patients with severe secondary mitral regurgitation and LVEF > 30% who remain symptomatic despite optimal clinical treatment and with low surgical risk.
Symptomatic patients with mitral stenosis (valve area ≤ 1.5 cm2) who are not suitable for percutaneous mitral commissurotomy.

Who cannot join

Emergency surgical valve replacement.
Surgical replacement of the aortic root.
Patients who did not return for follow-up examinations.
Patients with renal impairment as determined by creatinine level ≥ 2.5 mg/dL or end-stage renal disease requiring chronic dialysis.
Patients with stroke or transient ischemic attack within 6 months (180 days) before planned valve surgery.
Patients with acute myocardial infarction within 30 days before planned valve surgery.

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Patients with any known life-threatening non-cardiac disease that will limit the patient's life expectancy below 1 year.
Patients diagnosed with abnormal calcium metabolism and hyperparathyroidism.
LVEF ≤ 20%, as validated by the diagnostic procedure before planned valve surgery.
Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
Documented leukopenia (leukocytes < 3.5x10³/μL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L) or thrombocytopenia (platelet count < 50x10³/μL) accompanied by a history of bleeding diathesis and coagulopathy.
Patients who underwent organ transplantation.
Pregnant or breastfeeding.
Patients with a documented history of substance abuse (drugs or alcohol) in the last year before implantation.
Concomitant positioning of the left ventricular assist device.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul
Hospital Ana Nery - HAN/SESAB
Salvador, Estado de Bahia
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: Clinical Evaluation of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis -BIOPRO TRIAL

Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis

Read the detailed description

Multicenter, observational, retrospective, non-comparative, non-randomized study to determine the safety and clinical performance of the Bovine Pericardium Valvular Bioprosthesis in patients who required replacement of their native or bioprosthetic valve (aortic or mitral), according to ISO 14155 and ISO 5840.

Conditions: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation
Being tested: Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
Medical subject headings: Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.Device
Also called Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Heart Valve Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical success
Valve implantation without occurrences and without serious adverse events until hospital discharge.
Measured: Until discharge from the index hospitalization (an average of 7 days is expected).
Composite event
Defined as death, stroke, and/or reintervention after 1 year of follow-up.
Measured: 01 year

Secondary outcomes (13)

Extracorporeal circulation time AND Aortic clamping time (minutes)
Measured: during the procedure
Intensive care unit (ICU) time (days)
Measured: Until discharge from the index hospitalization (an average of 2 days is expected)
Length of in-hospital stay (days)
Measured: Until discharge from the index hospitalization (an average of 7 days is expected).
New York Heart Association (NYHA) dunctional class at 5 years post-implant compared to baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Measured: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Valve related adverse events
structural valve deterioration, non-structural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death
Measured: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Early rates AND late linearized rates AND actuarial rates of valve-related adverse events
thromboembolism, valve thrombosis, all bleeds, major bleeds, paravalvular leaks, severe paravalvular leaks, endocarditis, non-structural dysfunction, structural valve deterioration (rupture and calcification)
Measured: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Subject's average peak systolic gradient (mmHg) measurements at 5 years post-implant
Measured: 5 years post-implant
Subject's average mean systolic gradient (mmHg) measurements at 5 years post-implant.
Measured: 5 years post-implant
Subject's average effective orifice area measurements at 5 years post-implant
Measured: 5 years post-implant
Subject's average effective orifice area index (EOAI) measurements at 5 years post-implant
Measured: 5 years post-implant
Subject's average performance index measurements at 5 years post-implant
Measured: 5 years post-implant
Subject's average cardiac output measurements at 5 years post-implant
Measured: 5 years post-implant
Subject's amount of aortic valvular regurgitation at 5 years post-implant
Measured: 5 years post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202330 Oct 2023

First posted15 Jun 2023
Study start1 Jan 2023
Primary completion1 Jul 2023
Study completion30 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve InsufficiencyStudies 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: 913 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05902897
Sponsor's protocol ID: BIOPRO Trial
Status last verified: Jun 2023
First submitted: 11 May 2023
Last updated: 25 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis

All Aortic Valve Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis -BIOPRO TRIAL
ClinicalTrials.gov ID: NCT05902897
Acronym / sponsor ID: BIOPRO Trial
Conditions: Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation
Study type: Observational
Recruitment status: Completed
Enrolment: 913 participants (actual)
Lead sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
Study start: 1 Jan 2023 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 15 Jun 2023 (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.

Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis

Detailed description

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 undergoing valve replacement (aortic or mitral) with Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis, from 2013 to 2021.

Key inclusion criteria (30 listed)

Symptomatic patients with severe aortic insufficiency.
Asymptomatic patients with severe aortic insufficiency and left ventricular ejection fraction (LVEF) at rest ≤ 50%.
Patients with severe aortic insufficiency and undergoing coronary artery bypass graft surgery (CABG) or surgery of the ascending aorta or other valve.
Asymptomatic patients with severe aortic insufficiency and resting ejection fraction > 50% with severe left ventricular (LV) dilation: left ventricular end-diastolic diameter (LVDD) > 70 mm or left ventricular ejection fraction (LVEF) > 50 mm (or LVEF > 25 mm/m2 of body surface, in patients with small body size).
Symptomatic patients with severe high gradient aortic stenosis (mean gradient ≥ 40 mmHg or peak velocity ≥ 4.0 m/s).

Key exclusion criteria (16 listed)

Emergency surgical valve replacement.
Surgical replacement of the aortic root.
Patients who did not return for follow-up examinations.
Patients with renal impairment as determined by creatinine level ≥ 2.5 mg/dL or end-stage renal disease requiring chronic dialysis.
Patients with stroke or transient ischemic attack within 6 months (180 days) before planned valve surgery.

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
Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.Also: Replacement for a diseased, damaged, malformed aortic or mitral heart valveHeart Valve Replacement	Device	–

Primary outcome

Clinical success
Time frame: Until discharge from the index hospitalization (an average of 7 days is expected).
Valve implantation without occurrences and without serious adverse events until hospital discharge.
Composite event
Time frame: 01 year
Defined as death, stroke, and/or reintervention after 1 year of follow-up.

13 secondary outcomes

Extracorporeal circulation time AND Aortic clamping time (minutes)
Time frame: during the procedure
Intensive care unit (ICU) time (days)
Time frame: Until discharge from the index hospitalization (an average of 2 days is expected)
Length of in-hospital stay (days)
Time frame: Until discharge from the index hospitalization (an average of 7 days is expected).
New York Heart Association (NYHA) dunctional class at 5 years post-implant compared to baseline
Time frame: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Valve related adverse events
Time frame: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Early rates AND late linearized rates AND actuarial rates of valve-related adverse events
Time frame: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Subject's average peak systolic gradient (mmHg) measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average mean systolic gradient (mmHg) measurements at 5 years post-implant.
Time frame: 5 years post-implant
Subject's average effective orifice area measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average effective orifice area index (EOAI) measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average performance index measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average cardiac output measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's amount of aortic valvular regurgitation at 5 years post-implant
Time frame: 5 years post-implant

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 25 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Insufficiency

Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis

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.

Fernando Lucchese principal investigator

Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

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 Insufficiency and Aortic Valve Regurgitation, 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 30 inclusion and 16 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 25 Apr 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?

Clinical success (time frame: Until discharge from the index hospitalization (an average of 7 days is expected).). 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?

On the ClinicalTrials.gov record for NCT05902897.

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 25 Apr 2025.