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临床试验/NCT05839782
NCT05839782已完成不适用

Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 108 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
108
试验地点
1
主要终点
Survival after reintervention

研究概览

简要总结

The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.

However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.

Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • adult patients
  • failure of previous mitral valve repair which needed a new surgical treatment
  • group Re-PLM: patients reoperated with a new mitral valve repair
  • group Re-SVM: patients reoperated with a mitral valve replacement

排除标准

  • urgent/emergent procedures

结局指标

主要结局

Survival after reintervention

时间窗: through study completion, a minimum of 2 years

Time of survival after reintervention for failed mitral valve repair

次要结局

  • Risk factors for reintervention(through study completion, a minimum of 2 years)

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 Advanced and Research Therapies

Ospedale San Raffaele

研究点 (1)

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