NCT05902897已完成不适用
Clinical Evaluation of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis -BIOPRO TRIAL
Braile Biomedica Ind. Com. e Repr. Ltda.3 个研究点 分布在 1 个国家目标入组 913 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 913
- 试验地点
- 3
- 主要终点
- Clinical success
研究概览
简要总结
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
- •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.
- •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.
排除标准
- •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.
- •Concomitant positioning of the left ventricular assist device.
结局指标
主要结局
Clinical success
时间窗: 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
时间窗: 01 year
Defined as death, stroke, and/or reintervention after 1 year of follow-up.
次要结局
- Early rates AND late linearized rates AND actuarial rates of valve-related adverse events(at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Subject's average effective orifice area measurements at 5 years post-implant(5 years post-implant)
- 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)
- Subject's average peak systolic gradient (mmHg) measurements at 5 years post-implant(5 years post-implant)
- Subject's average mean systolic gradient (mmHg) measurements at 5 years post-implant.(5 years post-implant)
- Subject's average effective orifice area index (EOAI) measurements at 5 years post-implant(5 years post-implant)
- Subject's average performance index measurements at 5 years post-implant(5 years post-implant)
- Subject's average cardiac output measurements at 5 years post-implant(5 years post-implant)
- Subject's amount of aortic valvular regurgitation at 5 years post-implant(5 years post-implant)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve DilatationAortic Valve StenosisNCT02847546C. R. Bard25
已完成
不适用
BRight DCB First-in-Human StudyPeripheral Artery DiseaseNCT04525794Biotronik CRC Inc.48
已完成
不适用
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F IDSurgical WoundNCT03193021Cardiva Medical, Inc.204
已完成
不适用
BIOVALVE - I / II Clincial InvestigationHeart Valve DiseasesAortic Valve StenosisNCT02249000Biotronik AG68
已完成
不适用
Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit PatientsBlood GlucoseNCT00906490Edwards Lifesciences100