Belgian Mitraclip Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- cardiac mortality
研究概览
简要总结
The primary objective of the registry is to investigate and follow all patients treated with the MitraClip System in Belgium. This information is intended to contribute to decision making with regards to MitraClip therapy selection in patients with mitral regurgitation: (a) by establishing the clinical value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers/government in making coverage decisions.
In addition national data will be shared with European registries in order to increase the knowledge about the efficacy of this new technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe mitral regurgitation
- •symptomatic (NYHA class>1) despite optimal medical therapy
- •suitable anatomy for mitraclip implantation
- •too high risk for cardiac surgery
排除标准
- •<1 year life expectancy
结局指标
主要结局
cardiac mortality
时间窗: 2 years
residual mitral regurgitation (MR) post mitraclip
时间窗: at day 3-5 post mitraclip implantation
MR grade 1 tot 4, as assessed on echocardiography
surgical mitral valve intervention
时间窗: 2 years
hospitalization for heart failure
时间窗: 2 years
heart failure as primary reason of hospitalization
次要结局
- pericardial effusion(day 1-2 after mitraclip implantation)
- change in New York Heart Association (NYHA) classification(2 years)
- distance during 6 min walking test(1 year)
- Left ventricular (LV) remodeling(6 month)
- Acute renal failure requiring dialysis(up to one month after mitraclip implantation)
- urgent surgical mitral valve intervention(within 24h after procedure)
- Change in Left ventricular ejection fraction (LVEF)(6 month)
研究者
M Claeys
Prof dr
Universiteit Antwerpen