NCT01841554已完成不适用
Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation
Edwards Lifesciences21 个研究点 分布在 6 个国家目标入组 62 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 21
- 主要终点
- Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
研究概览
简要总结
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Moderate to severe functional Mitral Regurgitation (MR)
- •Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.
- •Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm
- •Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site)
- •Transseptal catheterization and femoral vein access is determined to be feasible
- •Subject is able and willing to give informed consent and follow protocol procedures
排除标准
- •Active bacterial endocarditis
- •Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
- •Heavily calcified annulus or leaflets
- •Subjects in whom transesophageal echocardiography is contraindicated
- •Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- •CRT implant within 3 months prior to procedure
- •Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- •Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (>70% by Ultra sound)
- •Renal insufficiency requiring dialysis
- •Life expectancy of less than twelve months
- •Subject is participating in concomitant research studies of investigational products
- •Mitral valve anatomy which may preclude proper device treatment
- •Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation
结局指标
主要结局
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
时间窗: 30 days
Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.
次要结局
- Performance [MLHFQ](Baseline, 6 and 12 months)
- Performance [Intra-subject Comparison - MR Severity](Baseline, discharge, 6 and 12 months)
- Performance [Full Analysis Data Set - MR Severity](Baseline, discharge, 6 and 12 months)
- Performance [6MWT](Baseline, 6 and 12 months)
研究者
研究点 (21)
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