跳至主要内容
临床试验/NCT00947921
NCT00947921终止不适用

POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study

Cardiochirurgia E.H.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Patients treated with restrictive Annuloplasty

干预措施: Plasty (Procedure)

Prosthesis

Active Comparator

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

发起方
Cardiochirurgia E.H.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Weltert

Project Leader Luca Weltert

Cardiochirurgia E.H.

研究点 (2)

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