EValuation of Outcomes of MitraCLip for the Treatment of Moderate Functional Mitral ValvE Regurgitation In Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change In Mitral Regurgitation
研究概览
简要总结
The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.
详细描述
Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation.
Secondary Objectives
- To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months.
- To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ.
Tertiary Objectives
- To evaluate the effects of MitraClip and medical therapy on change from baseline in functional capacity (distance walked on a 6MWT) at 12 and 24 Months.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life, as measured by the EQ5DL questionnaire, at 12 and 24 months.
- To evaluate the effects of MitraClip and medical therapy on freedom from progression to severe MR at 24 months as assessed by echocardiography.
- To evaluate the effects of MitraClip and medical therapy on change from baseline in LVEDVi at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MitraClip
Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction.
Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
干预措施: MitraClip (Device)
MitraClip
Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction.
Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
干预措施: Medical Therapy (Drug)
Medical Therapy
Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction.
Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
干预措施: MitraClip (Device)
Medical Therapy
Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction.
Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
干预措施: Medical Therapy (Drug)
结局指标
主要结局
Change In Mitral Regurgitation
时间窗: 24 months
To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation
次要结局
- Change in Quality of Life Assessment(12 months)
- Change in Mitral Regurgitation Severity at 12 Months(12 months)
- Change in Mitral Regurgitation Severity at 24 Months(24 months)