NCT03567278已完成不适用
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis
Symetis SA10 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年11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
- 40
- 试验地点
- 10
- 主要终点
- Safety endpoint
研究概览
简要总结
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
详细描述
A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via 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 the feasibility and performance of the implantation and the safety at 30-Day 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 older than 75 years;
- •Additive EuroSCORE > 9 and/or STS > 9%;
- •Severe symptomatic AS assessed by echocardiography, documented by a derived 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;
- •Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) [STJ>1.1xAAn] AND STJ<45mm by transoesophageal echocardiography;
- •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 Accident (TIA) or stroke in the last 3 months;
- •Untreated clinically significant 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 with a LV Ejection Fraction (LVEF) < 25% by echocardiography;
- •Calcified pericardium;
- •Septal hypertrophy;
- •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);
- •Major lung disease (FEV < 0.8 or FEV1% < 30% of normal);
- •Pulmonary hypertension;
- •History of bleeding diathesis or coagulopathy;
- •Hematologic disorder (WBC<3000mm3, Hb<9g/dL, platelet count <50000 cells/ mm3);
- •Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis;
- •Neurological disease severely affecting ambulation or daily functioning, including dementia;
- •Other procedure scheduled at the same time, whether surgery or percutaneous approach;
- •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
Safety endpoint
时间窗: 30 days
Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE
次要结局
- Mortality(30 days, 60 days, 3 months, 6 months and 12 months)
- Performance endpoint(Up to 24-hours post-procedure)
- MAVRE at follow-up(discharge or 7 days, 3 months, 6 months and 12 months)
- MACCE or Major Adverse Cardiac and Cerebrovascular Event(1 month, 3 months, 6 months and 12 months)
研究者
研究点 (10)
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