跳至主要内容
临床试验/NCT05836480
NCT05836480已完成不适用

Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2019年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
1
主要终点
Mortality

研究概览

简要总结

Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease.

Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+).

The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study group:
  • presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
  • presence of moderate residual mitral regurgitation at discharge.
  • Control group:
  • presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
  • presence of residual mitral regurgitation of at least mild grade at discharge.

排除标准

  • 未提供

结局指标

主要结局

Mortality

时间窗: through study completion, a minimum of 6 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele De Bonis

Chief of Cardiac Surgery of Advance and Research Therapies

Ospedale San Raffaele

研究点 (1)

Loading locations...

相似试验