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临床试验/NCT02783248
NCT02783248已完成不适用

French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results

French Cardiology Society1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
301
试验地点
1
主要终点
Event free survival at 3 years

研究概览

简要总结

The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

详细描述

This is a multicenter prospective observational study conducted in French medico-surgical sites.

The Percutaneous Mitral Commissurotomy (PMC) is the standard treatment for Mitral stenosis (MS) in patients with rheumatic favorable characteristics. In Western countries the MS reaches older patients with less favorable characteristics, including the presence of mitral calcifications. Calcifications are a factor of poor outcome of the PMC. The scanner appears as a useful examination for their study but is not carried out systematically. The prediction of late results of the PMC is particularly important in patients with non-ideal characteristics which form a particularly heterogeneous population. A score of late results of the PMC on the wider western series was recently released but has not to date received external validation. In this score, prediction results was multifactorial, with a consideration of paramount clinical factors, but also a prognostic significance of mitral calcifications.

The validation of predictive score of late results of the PMC, with the analysis of calcifications, would better select patients who may best benefit from PMC and those for which the surgical management is preferred.

The aim of this study is to validate an external sample predictive score of the event-free survival in patients who have had a good immediate result of the PMC.

This study, purely observational, does not create any special procedure outside the patient's usual care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years
  • This will include all consecutive patients with rheumatic MS referred for PMC
  • Patients who agreed to participate in the study, with signed consent

排除标准

  • Contraindication to the PMC
  • Contraindication to non injected scanner for centers performing a scanner
  • Patient Refusal to participate in the study

结局指标

主要结局

Event free survival at 3 years

时间窗: 3 years

Measurement of event-free survival after good result of the PMC, observed in our study. The composite endpoint event-free survival is defined as: cardiovascular survival without reoperation on the mitral valve and patient in NYHA I-II at last follow

次要结局

未报告次要终点

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (1)

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