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

NCT05902897 | Completed DMC

• 1 other identifier: BIOPRO Trial
• Study Type: observational
• Target: 913
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Aortic Valve Insufficiency; Aortic Valve Regurgitation; Aortic Valve Stenosis; Aortic Valve Incompetence; Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Stenosis; Mitral Valve Incompetence

Outcome Measures

Primary Outcomes (2)

• Clinical success

  Valve implantation without occurrences and without serious adverse events until hospital discharge.

  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.

  01 year

Secondary Outcomes (13)

• Extracorporeal circulation time AND Aortic clamping time (minutes)

  during the procedure

• Intensive care unit (ICU) time (days)

  Until discharge from the index hospitalization (an average of 2 days is expected)

• Length of in-hospital stay (days)

  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

  at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

• Valve related adverse events

  at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years

Interventions

Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis. DEVICE

Heart Valve Replacement

Also known as: Replacement for a diseased, damaged, malformed aortic or mitral heart valve

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

You may qualify if:

• (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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (3)

Hospital Ana Nery - HAN/SESAB

Salvador, Estado de Bahia, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

Porto Alegre, Rio Grande do Sul, Brazil

Location

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis; Mitral Valve Insufficiency; Mitral Valve Stenosis

Interventions

Replantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Fernando Lucchese

  Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 15, 2023
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: October 30, 2023
• Last Updated: April 25, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)