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