POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting for surgery due to functional mitral regurgitation
排除标准
- •Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction
研究组 & 干预措施
Plasty
Patients treated with restrictive Annuloplasty
干预措施: Plasty (Procedure)
Prosthesis
Patients treated with valve replacement
干预措施: Prosthesis (Procedure)
结局指标
主要结局
Mortality
时间窗: 1 year of follow up after discharge from hospital
次要结局
- Freedom from reintervention(1 year of follow-up after discharge from hospital)
研究者
Luca Weltert
Project Leader Luca Weltert
Cardiochirurgia E.H.
