NCT01899573已完成不适用
A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cardiovascular events
研究概览
简要总结
The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce 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
- •Subjects with clinically significant mitral regurgitation (MR 2+ and above)
- •Ejection Fraction ≥ 25%
- •Stable cardiac medical regimen for heart failure for at least 1 month
- •Stable NYHA Classification for at least 1 month
- •Subject is eligible for cardiac surgery
- •The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
排除标准
- •Myocardial infarction within 90 days of the intended treatment with the device
- •Prior surgical, transcatheter, or percutaneous mitral valve intervention
- •Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease
- •Hemodynamic instability or the need for emergent surgery
- •Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
- •Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
- •Echocardiography evidence of primary mitral valve disease causing MR or MS,
- •Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm2
- •Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
- •Estimated GFR of <30ml/min/1.73m2
- •Greater than mild mitral annular calcification observed by fluoroscopy
- •Presence of aortic valve prosthesis
- •Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
- •Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
- •Active bacterial endocarditis
- •History of bleeding diathesis or coagulopathy
- •History of stroke within the prior 6 months
- •Subjects in whom anticoagulation is contraindicated
- •Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device.
- •Concurrent medical condition with a life expectancy of less than 12 months
- •Currently participating in an investigational study
- •Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
- •Subjects with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair
- •Any cardiac resynchronization therapy within the last 3 months prior to treatment
- •Subjects on high dose steroids or immunosuppressant therapy
- •Female subjects who are pregnant, of child bearing potential or lactating
- •Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
研究组 & 干预措施
Treatment
Experimental
干预措施: AccuCinch® Ventriculoplasty System (Device)
结局指标
主要结局
Major adverse cardiac and cardiovascular events
时间窗: 30 day
次要结局
未报告次要终点
研究者
研究点 (1)
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