NCT01347125终止早期 1 期
ImCardia for DHF - Safety and Functionality
CorAssist Cadiovascular Ltd.0 个研究点目标入组 19 人开始时间: 2008年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 主要终点
- Safety: Adverse event reporting
研究概览
简要总结
This study is designed to evaluate the ImCardia safety and to demonstrate system functionality in patients undergoing AV replacement with respect to 36 months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female able to understand and sign a informed consent
- •Be 50 years of age or older
- •NYHA class III, IV
- •Candidates for aortic valve replacement due to aortic stenosis.
- •Agrees to attend all follow- up evaluations
排除标准
- •Free wall thickness less than11.5mm
- •Adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.)
- •Presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of ImCardia™device Attachment screw.
- •Likely to be need CABG following the implantation of the ImCardia™
- •Intra-cardiac thrombus/mass
- •Myocarditis
- •Acute/chronic pericarditis
- •Not a candidate for sternotomy
- •Active infection
- •Stroke, surgery or ICD within 3 months
- •Acute coronary syndrome during the past 6 months
- •Left ventricular regional wall motion abnormalities
- •Significant valvular disease other that aortic stenosis
- •Significant pulmonary disease
- •A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator
- •Participating in another trial (other than non-therapeutic or interventional observation) within the last 60 days.
- •History of noncompliance to medical therapy
研究组 & 干预措施
ImCardia
Experimental
Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device
干预措施: ImCardia Device (Device)
AVR control group
No Intervention
Aortic stenosis patients candidates for aortic valve replacement
结局指标
主要结局
Safety: Adverse event reporting
时间窗: 36 month
Adverse event reporting will continue up to 36 month follow up. Any complication attributed to the device will be recorded. Any Major Adverse Cardiac Event (MACE) will be evaluated in a safety committee composed from company representative and a cardiosurgeon which is not part of the company
次要结局
- Functionality - Successful Device implantation(Immediately post implantation day)
研究者
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