NCT01112566已完成不适用
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Medtronic Bakken Research Center7 个研究点 分布在 5 个国家目标入组 152 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 7
- 主要终点
- Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.
研究概览
简要总结
The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher);
- •Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care
排除标准
- •Heavily calcified valves
- •Valvular retraction with severely reduced mobility
- •Active bacterial endocarditis
- •Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints;
- •Life expectancy of less than one year;
- •Pregnant or desire to be pregnant within 12 months of the study treatment;
- •Under 18 years or over 85 years of age.
结局指标
主要结局
Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.
时间窗: screening
Assess the percentage of patients that are chronically relieved from mitral valve dysfunction
时间窗: 6-12 months follow up
Determine the level of mitral valve regurgitation in patients
时间窗: 6-12 months post-surgery
次要结局
未报告次要终点
研究者
研究点 (7)
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