NCT02602613已完成不适用
AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
Valcare Medical Ltd.9 个研究点 分布在 4 个国家目标入组 4 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 9
- 主要终点
- Safety - Freedom from major SAE's at 30 days following procedure
研究概览
简要总结
A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.
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
- •Patient age ≥18
- •The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
- •NYHA functional capacity ≥2
- •The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
- •The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
- •The patient is willing to provide Informed consent
排除标准
- •Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
- •Life expectancy of less than twelve months.
- •Heavily calcified annulus or leaflets.
- •Previous or active endocarditis.
- •Active infection.
- •A previously implanted prosthetic mitral valve or annuloplasty ring/band.
- •The patient is contraindicated to general anesthesia.
- •Pregnant (urine HCG test result positive) or lactating patient.
- •Drug or alcohol abuse.
- •Participation in concomitant research studies of investigational products that will interfere with the study.
研究组 & 干预措施
AMEND
Experimental
干预措施: AMEND Mitral Valve Repair System (Device)
结局指标
主要结局
Safety - Freedom from major SAE's at 30 days following procedure
时间窗: 30 days
Freedom from major SAE's at 30 days following procedure
Technical success of implantation
时间窗: End of procedure
Ring location and attachment based on echocardiography
次要结局
- Safety - Freedom from major SAE's at 6 months following procedure(6 months)
研究者
研究点 (9)
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