Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- A composite of adverse cardiovascular events
研究概览
简要总结
Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left 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
- Double (Care Provider, Outcomes Assessor)
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
- •Patients undergoing left heart valve surgery with mild tricuspid regurgitation;
- •Patients aged 18-80 years;
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •Infective endocarditis within 3 months;
- •Primary tricuspid regurgitation;
- •Isolated tricuspid regurgitation
- •Lactating women and suspected pregnant or pregnant women;
- •Patients with mental disorders, drug and alcohol dependence;
- •Those who participated in other clinical trials one month before the trial;
- •Refusal to participate in this study without informed consent.
结局指标
主要结局
A composite of adverse cardiovascular events
时间窗: 2 years after surgery at follow-up
a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation from baseline by two grades or the presence of severe tricuspid regurgitation, or death.
次要结局
未报告次要终点
研究者
Hong Liu
Principal Investigator of Cardiovascular Surgery
Nanjing Medical University