NCT00677638Unknown不适用
Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease
Ventor Technologies6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure
研究概览
简要总结
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.
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
- •Patient understands the implications of participating in the study and provides informed consent
- •Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
- •Age >75 years
- •Severe, aortic stenosis (echocardiographically derived mean gradient > 40 mm Hg, and/or jet velocity > 4m/s, or an initial aortic valve area of < 0.8 cm2)
- •Symptoms related to the aortic valve disease, as demonstrated by NYHA Functional Class II or greater
- •EuroSCORE scale of >9 points indicating a predicted risk for mortality of >11% according to the logistic EuroSCORE
- •Echocardiographically determined anteroposterior aortic annulus diameter of >19 and <23 mm
- •Echocardiographically determined sinotubular junction diameter of ≥23 mm
排除标准
- •Congenital unicuspid or bicuspid aortic valve
- •Fused commissures
- •Severe eccentricity of calcification
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- •Severe left ventricular dysfunction (LVEF < 25%)
- •More than mild right ventricular dysfunction
- •Hypertrophic obstructive cardiomyopathy
- •Moribund patients, or patients with a noncardiac disease limiting by itself life expectancy to less than 12 months
- •Known hypersensitivity or contraindication to any study medication
- •Known sensitivity to contrast medium that cannot be adequately controlled with pre-medication
- •Known allergy or sensitivity to Nitinol
- •Sepsis, or acute endocarditis
- •Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.
- •Renal insufficiency and/or end stage renal disease requiring chronic dialysis
- •Liver disease as indicated by jaundice, ascites, ALT/AST > 3 x ULN, elevation of total bilirubin > 1.5 mg/dl, albumin < 3.0 g/l, or INR > 1.5 (if not on anticoagulation).
- •Significant lung disease (e.g. FEV1 < 1.2L or FEV1 < 50%).
- •Active peptic ulcer or GI bleeding within 3 months from the planned index procedure
- •Untreated clinically significant coronary artery disease requiring revascularisation
- •Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance
- •Peripheral vascular disease, including abdominal and thoracic aortic disease, which could pose a problem for eventual transarterial mechanical support (e.g. Intraaortic Balloon Pump)
- •Need for emergency surgery, cardiac or noncardiac
- •History of myocardial infarction in the last 6 weeks.
- •History of TIA or stroke in the last 6 months.
- •Any therapeutic invasive cardiac procedure, except aortic balloon valvuloplasty, performed within 30 days from the planned index procedure, or 6 months, in case of implantation of drug-eluting stents.
- •Uncontrolled atrial fibrillation
- •Pre-existing aortic valve replacement
- •Severe (greater than 3+) mitral regurgitation
- •Severe (greater than 3+) aortic regurgitation
- •Patient is currently enrolled in another investigational device or drug trial
结局指标
主要结局
Stable device placement and adequate function as assessed by angiography and echocardiography immediately post-procedure
时间窗: day one
A composite of any death, myocardial infarction, or disabling stroke at 30 days post-procedure
时间窗: 30 days
次要结局
- Device success and the absence of periprocedural MACCEs at post-operative day 1(day one)
- Any of the following adverse events: death, myocardial infarction, disabling stroke, repeat aortic valve procedure, cardiogenic shock, or endocarditis at 30 days(30 days)
- Any of the following adverse events: death, disabling stroke, repeat aortic valve procedure or endocarditis at 6 months(6 months)
- Freedom from death at 1 year(1 year)
- Functional improvement from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year(1 year)
- Peak & mean pressure gradient, derived calculated measures of prosthetic valve function, aortic regurgitation - assessed by echocardiography immediately after deployment, at POD 1, 30 days, 6 months and 5 years annually(5 years)
研究者
研究点 (6)
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