Hemodynamic Estimation Per Procedure of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure.
研究概览
简要总结
this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound.
The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Woman or man over 18 years old
- •Patient with symptomatic mitral leakage (grade 3+ or 4+) at high surgical risk defined as:
- •Age ≥ 75 years and an STS score ≥ 6%, or, according to MVARC, at least 1 fragility index or at least 1 organ fragility criterion or at least 1 operative risk criterion. MVARC recommendations are defined in the appendix.
- •Age <75 years and an STS score> 8%, or, according to MVARC, at least 1 fragility index or at least 1 organ fragility criterion or at least 1 operative risk criterion. MVARC recommendations are defined in the appendix.
- •Patient rejected for surgery.
- •Patient with a life expectancy of over 1 year.
- •Patient affiliated or beneficiary of a social security scheme.
- •Patient having been informed and having signed a written consent.
排除标准
- •Patient with unfavorable ultrasound parameters (for example: patient with insufficient mitral surface).
- •Patient with recent or active infection.
- •Patient with a contraindication to the transseptal puncture.
- •Patient with valve anatomy incompatible with the placement of the device.
- •Patient with an anomaly of the tricuspid valve justifying a surgical intervention.
- •Patient who has had a percutaneous cardiovascular procedure within the previous 30 days.
- •Patient who had heart surgery in the previous 30 days.
- •Patient with a history of surgery on the mitral valve.
- •Patient having had a stroke in the previous 30 days.
- •Patient participating in another clinical study.
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- •Pregnant, breastfeeding or parturient woman.
- •Patient hospitalized without consent.
结局指标
主要结局
Percentage improvement in the mean arterial pressure / mean left atrium pressure ratio measured at the end of the procedure.
时间窗: 6 months
The percentage of improvement is defined by the value (B-A) / A \* 100, with A = mean arterial pressure / mean left atrium pressure ratio at the start of the procedure and B = mean left atrium pressure / mean arterial pressure ratio at the end of the procedure.
次要结局
未报告次要终点