NCT00256165已完成4 期
Left Ventricular Regression European Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve
研究概览
简要总结
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with echocardiography (2-dimensional [2D] mandatory; 3-dimensional [3D] in sites where the technology is available).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires, for the first time, isolated aortic valve replacement due to aortic stenosis or mixed aortic stenosis disease etiology when aortic stenosis is predominant and aortic regurgitation is mild.
- •Patient is of legal age in the host country.
- •Patient (or legal guardian) has signed a study specific informed consent form
排除标准
- •Patient was previously operated on with any heart surgery including heart valve replacement or coronary artery bypass graft (CABG); or underwent any form of myocardial revascularization in the past (including stents), etc.
- •Patient requires any concomitant heart surgery other than the isolated native aortic heart valve replacement and concomitant ascending aortic replacement (e.g not allowed are: multiple valve replacements or concomitant CABG, pacemaker insertions, or severe septal hypertrophy needing surgical excision, etc.)
- •Patient has unstable angina
- •Patient is in New York Heart Association functional class IV
- •Patient has significant abnormality in wall motion
- •Patient is affected by active endocarditis.
- •Patient has a cardiac pacemaker or automatic implanted cardiac defibrillator
- •Patient is affected by acute aortic dissection.
- •Patient is in chronic and persistent atrial fibrillation
- •Patient receives hemodialysis therapy
- •Patient has a medical condition which contraindicates implantation of the SJM Epic and Epic™ Supra Porcine Bioprosthetic Heart Valve (e.g. renal failure or abnormal calcium metabolism).
- •Patient has aneurysmal clips or carotid artery vascular stents
- •Patient has a neurostimulator
- •Patient has an implanted or external drug infusion device (e.g. insulin pump)
- •Patient has a bone growth/fusion stimulator
- •Patient has a cochlear, otologic, or ear implant
- •Patients with severe claustrophobia in which medical sedation is contraindicated or unable to resolve anxiety sufficiently
- •Patients with ocular foreign body (e.g. metal shavings)
- •Patient is pregnant or nursing
结局指标
主要结局
The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve
时间窗: At 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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