Minimally Invasive Tricuspid Surgery Versus Medical Treatment for Severe Tricuspid Regurgitation After Left-sided Valve Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- the rate of all-cause death, re-hospitalization due to right heart failure or both of them
研究概览
简要总结
Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage. Over the past 3 decades, with the advances in minimally invasive surgical techniques, operative mortality after reoperation for severe TR has significantly decreased from 30% to 3-8%, leading to a gradual shift from medical therapy alone to surgery in those patients. However, there has been no consensus on the clinical benefit of minimally invasive tricuspid surgery over medical therapy for severe TR after LSVS.
详细描述
In this multi-center randomized controlled trial, patients with severe TR after LSVS will be recruited. The patients will be randomly assigned to surgery plus medical therapy (surgery group) or medical therapy alone (control group). The primary outcome will be a composite of all-cause mortality, re-admission for right heart failure or the composite. Furthermore, echocardiography-based measurement of right heart function, New York Heart Association functional class, liver and kidney function, and quality of life will be compared between the 2 groups. All outcomes will be assessed at baseline and 6, 12 and 24 months after randomization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography.
- •A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement.
- •Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60 mmHg with pulmonary vascular resistance <6 woods unit.
- •Age ≥ 18 years.
- •Able to sign Informed Consent forms.
排除标准
- •TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease.
- •Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures.
- •Prior surgical or percutaneous tricuspid valve intervention.
- •Evidence of an acute myocardial infarction in the prior 90 days
- •Contraindications to cardiopulmonary bypass or the expected operative mortality >30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).
- •Any comorbidity with life expectancy <2 years
- •Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol.
- •Pregnancy at the time of randomization.
结局指标
主要结局
the rate of all-cause death, re-hospitalization due to right heart failure or both of them
时间窗: 2 years
the rate of all-cause death, re-hospitalization due to right heart failure or both of them
次要结局
- life quality scores(2 years)
- New York Heart Association functional class(2 years)
- right heart function(2 years)
- liver function(2 years)
- kidney function(2 years)