NCT02829749撤回不适用
A European, Multicenter, Randomized Study Comparing the Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation
研究概览
简要总结
The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Severe primary mitral regurgitation (grade 3+ or 4+)
- •Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines:
- •Symptomatic patients and/or
- •LV (Left Ventricular) dysfunction : LVESD ≥45 mm and/or 30≤ LVEF ≤60%
- •Leaflet prolapse of P2 and/or A2
- •Predicted coaptation length > 4 mm
- •Candidates for surgical mitral valve repair according to heart team
- •Patient able to sign an informed consent form
- •Patient benefiting from a social insurance system or a similar system
排除标准
- •Asymptomatic patients with preserved LV function
- •Complex mechanism of MR (leaflet perforation, severe calcifications, commissural extension, etc)
- •Secondary MR
- •Predicted post-repair coaptation length less than 4 mm
- •Atrial fibrillation
- •Inflammatory or infective valve disease
- •Severe LV dilation (DTD > 65 mm)
- •Significant mitral annulus dilatation (D > 45 mm)
- •Surgical indication of tricuspid annulus
- •Contraindication to TEE (transesophageal echocardiographic ) or inadequate image quality
- •Need for any other concomitant cardiac procedure
- •Concurrent medical condition with a life expectancy of less than 24 months
- •Patient unable to understand the purpose of the trial
- •Patient < 18 years old
- •Participation to another trial that would interfere with this trial
- •Pregnancy
结局指标
主要结局
Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation
时间窗: 1 year
次要结局
- Overall survival(12 months)
- mitral regurgitation > 2+(12 months)
- Mitral valve reoperation free survival(12 months)
- Change in quality of life score(12 months)
- Number of device success(30 days)
- Freedom from rehospitalization for heart failure(12 months)
- Change in functional evaluation (6 minute walk test )(12 months)
- Proportion of patients with any major adverse events(30 days)
- Change in functional evaluation (NYHA)(12 months)
研究者
研究点 (1)
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