ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Freedom from all-cause mortality at 30 day Follow Up
研究概览
简要总结
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
详细描述
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 75 years of age
- •Additive EuroSCORE > 9
- •Severe AS assessed by echocardiography and documented by a mean gradient > 40mmHg and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²
- •NYHA Functional Class > II
- •Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
- •Patient understands the implications of participating in the study and provides signed informed consent
排除标准
- •Congenital unicuspid or bicuspid aortic valve
- •Severe eccentricity of calcification
- •Severe mitral regurgitation (> 2°)
- •Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- •Severe transapical access problem, non-reachable LV apex
- •Previous surgery of the LV using a patch, such as the Dor procedure
- •Presence of apical LV thrombus
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Acute myocardial infarction (AMI) within 1 month prior to the procedure
- •PCI within 1 month prior to the procedure
- •Previous transient ischemic attack (TIA) or stroke in the last 3 months
- •Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- •Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump
- •Severe left ventricular dysfunction (LVEF) < 30% by echocardiography
- •Calcified pericardium
- •Septal hypertrophy unacceptable for transapical procedure
- •Primary hypertrophic obstructive cardiomyopathy (HOCM)
- •Active infection, endocarditis or pyrexia
- •Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
- •Significant hepatic involvement (Child > B)
- •Severe COPD requiring home oxygen
- •History of bleeding diathesis or coagulopathy
- •Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
- •Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
- •Neurological disease severely affecting ambulation or daily functioning, including dementia
- •Another surgical or percutaneous procedure scheduled at the same time
- •Emergency procedure
- •Life expectancy < 12 months due to non-cardiac co-morbid conditions
- •Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol
- •Currently participating in an investigational drug or another device study
结局指标
主要结局
Freedom from all-cause mortality at 30 day Follow Up
时间窗: 30-Day Follow-up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Freedom from all-cause mortality at 12 months Follow Up
时间窗: 12 months Follow-Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
次要结局
- Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.(30-Day and 12-Month)
- Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.(30-Day and 12-Month Follow-up)
- Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;(30-Days and at 12 Months Follow-up)
- Functional Improvement from baseline(30-Days and 12-Month Follow-up)
- Procedural success(24 hours Post-Procedure)