EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Left ventricular diastolic remodelling
研究概览
简要总结
This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.
详细描述
Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients.
Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity.
EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.
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
- Single (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
- •Moderate functional mitral regurgitation (2+, 2-3+)
- •Left ventricular ejection fraction >20%
- •LVEDV 75-110 ml/m2
- •Symptomatic heart failure (NYHA Class II-IV)
排除标准
- •Left ventricular ejection fraction < 20%
- •Severe functional mitral regurgitation
- •Recent coronary artery bypass graft surgery (CABG)
- •Untreated significant coronary artery disease
- •Mitral valve area < 4.0cm2
- •Severe pulmonary hypertension
结局指标
主要结局
Left ventricular diastolic remodelling
时间窗: 12 months
Change in indexed left ventricular diastolic volume (LVEDV)
Functional capacity as measured by 6 minute walk test
时间窗: 12 months
Change in distance walked on six-minute walk test
次要结局
- Quality of Life Measurement(12 months)
- Mitral regurgitation Severity (EROA)(12 months)
- Mitral regurgitation Severity (RV)(12 months)