CoreValve® System Australia/New Zealand Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 634
- 试验地点
- 11
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
研究概览
简要总结
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk
详细描述
Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented severe aortic valve stenosis
- •Access vessel diameter >6 mm as defined pre procedure via angiographic measure
- •Aortic valve annulus diameter ≥ 20 mm and < 29 mm as defined pre procedure by echocardiographic measure
- •Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
- •Native aortic valve disease, defined as valve stenosis with an aortic valve area<1cm2 (<0.6cm2 /m2) as defined pre procedure by echocardiographic measure
- •AND (Assessment of Surgical Risk)
- •Age ≥ 80 years
- •Surgical risk calculated with logistic EuroSCORE ≥ 20%,
- •Age ≥ 65 years with one or two (but not more than 2) of the following criteria:
- •Cirrhosis of the liver (Child class A or B)
- •Pulmonary insufficiency : VMS < 1 liter
- •Previous cardiac surgery (CABG, valvular surgery)
- •Porcelain aorta
- •Pulmonary hypertension > 60 mmHg and high probability of cardiac surgery for other than valve replacement
- •Recurrent pulmonary embolus
- •Right ventricular insufficiency
- •Thoracic burning sequelae contraindicating open chest surgery
- •History of mediastinum radiotherapy
- •Severe connective tissue disease resulting in a contraindication to surgery
- •Cachexia (clinical impression)
- •Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
- •Any sepsis, including active endocarditis.
- •Recent myocardial infarction (<30 days)
- •Any left ventricular or atrial thrombus as determined pre procedure by echocardiography
- •Uncontrolled atrial fibrillation
- •Mitral or tricuspid valvular insufficiency (> grade II)
- •Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
- •Evolutive or recent CVA (cerebrovascular accident), (<3 months)
- •Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
- •Symptomatic carotid or vertebral arteries narrowing (> 70%) disease
- •Abdominal or thoracic aortic aneurysm
- •Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
- •Evolutive disease with life expectancy less than one year
- •Creatinine clearance < 20 ml/min
- •Active gastritis or known peptic ulcer disease
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
时间窗: 30 days
Defined as a composite of all cause death, myocardial infarction(MI) (Q-wave \& non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)
Cardiac-related Death
时间窗: 30 days
Defined as all death resulting from a cardiac cause or complications of a cardiac procedure and / or death of an unknown cause; this category includes valve-related deaths and non-valve-related cardiac deaths (e.g. congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).
Percentage of Participants With Overall Device Success
时间窗: 24-48 hours after the procedure or before the discharge
* Vascular access, delivery and deployment of the device, and retrieval of the delivery system * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function) * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted * No occurrence of in-hospital MACCE
次要结局
- Myocardial Infarction(30 days)
- All-Cause Mortality(30 days)
- Stroke(30 days)
- Re-intervention(30 days)