Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 9
- 主要终点
- Composite Major Adverse Event (MAE) Free Rate
研究概览
简要总结
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.
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
- •Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm² (<0.6cm2/m2) as determined by echocardiographic measure,
- •≥ 75 years, or
- •Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or
- •One or two (but not more than 2) of the following complicating factors:
- •Cirrhosis of the liver (Child class A or B),
- •Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) < 1 liter,
- •Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),
- •Pulmonary hypertension > 60 mmHg and high risk of cardiac surgery other than valve replacement,
- •Porcelain aorta
- •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 (BMI ≤ 18 kg/m²),
- •Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure,
- •Ascending aorta diameter £ 45 mm at the sino-tubular junction, and
- •Signed Informed Consent.
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,
- •Any sepsis, including active endocarditis,
- •Recent myocardial infarction (< 30 days),
- •Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
- •Any left ventricular or atrial thrombus diagnosed by echocardiography,
- •Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),
- •Mitral or tricuspid valvular insufficiency ( > grade II),
- •Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve),
- •Any condition considered as contraindication for extracorporeal assistance,
- •Evolutive or recent CVA (cerebro vascular accident),
- •Poly arterial patients with either:
- •Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
- •Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or
- •Abdominal or thoracic aortic aneurysm,
- •Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion,
- •Evolutive disease with life expectancy less than one year,
- •Creatinine clearance < 20 ml/min,
- •Pregnancy, and
- •Enrolled in another investigational study.
研究组 & 干预措施
CoreValve
干预措施: Medtronic CoreValve System (Device)
结局指标
主要结局
Composite Major Adverse Event (MAE) Free Rate
时间窗: 30 (+7) days post procedure
Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.
次要结局
- Composite Technical Device Success(Was assessed during the procedure and completed once the procedure was conlcluded)