LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility: Study follow-up rate and length
研究概览
简要总结
Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR.
The standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS).
Previous studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients ≥18 years of age
- •Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease
- •Planned surgical mitral valve repair
- •Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline
- •Pulmonary vascular resistance ≤ 4 Wood units
排除标准
- •Secondary causes of MR and mixed mitral valve disease
- •Infective endocarditis within 30-days
- •Any prior mitral valve intervention
- •Need for emergency intervention or surgery
- •Left ventricular ejection fraction 2+
研究组 & 干预措施
Mitral valve repair with creation of an 8m inter-atrial shunt
干预措施: Mitral valve repair with creation of an 8 mm inter-atrial shunt (Other)
Mitral valve repair without a shunt
干预措施: Mitral valve repair with creation of an 8 mm inter-atrial shunt (Other)
结局指标
主要结局
Feasibility: Study follow-up rate and length
时间窗: 30 Months
Process, Resources, Management, Scientific
Feasibility: recruitment rate
时间窗: 30 Months
Process, Resources, Management, Scientific
Feasibility: Success rate of intervention
时间窗: 30 Months
Process, Resources, Management, Scientific
次要结局
未报告次要终点
