MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.
详细描述
In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with recurrent mitral regurgitation treated with a MitraClip®.
排除标准
- •Patient with endocarditis,
- •Patients with torn mitral valve ring.
结局指标
主要结局
Survival
时间窗: 1 year
MR (mitral regurgitation) grade after clip treatment
时间窗: 1 year
Scale 0-4
次要结局
- NYHA status at latest follow up(1 year)
- Distance in 6 minute walk test at latest follow up(1 year)
- MR (mitral regurgitation) grade at latest follow up(1 year)
- LVEF (left ventricular ejection fraction) at latest follow up(1 year)
- LVEDV (left ventricular enddiastolic volume) at latest follow up(1 year)
- LVEDD (lef ventricular enddiastolic diameter) at latest follow up(1 year)
- Mean mitral valve gradient(1 year)
- Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve(1 year)
- Procedural complications(index procedure)
- Clip success based on type of sMVR(index procedure)
研究者
Daniel Braun, MD
MD
LMU Klinikum