Early Transcatheter Mitral Valve Repair After Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 63
- 主要终点
- All-cause death or Cumulative Heart Failure hospitalizations
研究概览
简要总结
To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.
详细描述
Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery.
Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (intervention group) or to no MitraClip device (Control group).
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic moderate to severe or severe MR after acute MI
- •Age > 18 years
- •Based on the following classification recently published in "Transcatheter Mitral Edge-to-Edge Repair for Treatment of Acute Mitral Regurgitation" by M. Shuvy et al. (Can J Cardiol. 2023) patients will be included if categorized in Type 2, 3 or 4:
排除标准
- •Primary MR (e.g. papillary muscle rupture)
- •Accepted for CABG
- •Presence of cardiogenic shock (AMR type 1)
结局指标
主要结局
All-cause death or Cumulative Heart Failure hospitalizations
时间窗: 12 months
Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations
次要结局
未报告次要终点
研究者
Isaac Pascual Calleja
MD, PhD
Fundación para la Investigación Biosanitaria del Principado de Asturias