Surgery of Secondary Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Difference in tricuspid annular plane systolic excursion
研究概览
简要总结
Currently, in cardiology/cardiosurgery the indicators for the surgical correction of secondary tricuspid regurgitationare unclear. AIM: To compare right ventricle structural and functional changes after operation in patients with secondary tricuspid regurgitation with severe mitral /aortic valve pathology, requiring surgical intervention; define the factors influencing major adverse cardiac events depending on the operation/non-operation due to moderate tricuspid regurgitation. This study intends to include 200-300 people and will occur over 5 years with an additional 3-year follow-up.
详细描述
Background It has been demonstrated in recent large patient monitoring registers that the presence of even mild secondary tricuspid regurgitation (TR) has a significant effect on life expectancy. Currently, in cardiology/cardiosurgery the indicators for the surgical correction of secondary TR are unclear. In this area, international guidelines lack randomized studies and are based on a C level of evidence. C level evidence is based solely on the opinion of experts, retrospective, and/or observational studies. The first indicator for tricuspid valve (TV) surgery is considered to be a combination of TR with severe aortic or mitral valve lesions that require surgical treatment. However, the level of indicators for moderate corrections in such situations is typically II A-B. At the C level of evidence there is no consensus for surgical treatment of such a defect in the international community. Severe TR indicators are Class I while the evidence remains C level because it is not well established that surgical treatment improves the prognosis of these patients. There is a lack of information about the structural and functional changes of the right ventricle after surgery depending on the degree of TR.
Aims and objectives of studying AIM: To compare right ventricle structural and functional changes after operation in patients with secondary tricuspid regurgitation with severe mitral /aortic valve pathology, requiring surgical intervention; define the factors influencing major adverse cardiac events depending on the operation/non-operation due to moderate tricuspid regurgitation.
OBJECTIVES:
- To study tricuspid regurgitation parameters affecting the long-term prognosis for the surgical correction of severe secondary tricuspid regurgitationof patients with severe aortic/mitral valve pathology requiring surgical treatment.
- To define hemodynamic parameters of patients with moderate tricuspid regurgitation, when surgical treatment of this defect gives an additional improvement in the short-term and long-term prognosis following surgical treatment of severe aortic/mitral valve diseases.
- To study changes in contractility parameters in the right ventricle and tricuspid valve function after reconstructive surgery over a period of 3 years.
Methods and study plans This study intends to include 200-300 people and will occur over 5 years with an additional 3-year follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Indication left-side valve surgery
排除标准
- •Unwillingness to give informed consent and to enter a regular follow-up program.
- •Prior surgical or percutaneous mitral valve intervention
- •Contraindication to cardiopulmonary bypass (CPB)
- •Clinical signs of cardiogenic shock at the time of randomization
结局指标
主要结局
Difference in tricuspid annular plane systolic excursion
时间窗: 3 month, 1 year, 3 year
Difference in TAPSE between of pre- and post- operation
Difference in fraction of area contraction of right ventricle
时间窗: 3 month, 1 year, 3 year
Difference in fraction of area contraction between pre- and post- operation
Difference in right ventricle global strain rate
时间窗: 3 month, 1 year, 3 year
Difference in right ventricle global strain rate between of pre- and post- operation
tricuspid regurgitant volume
时间窗: 3 month, 1 year, 3 year
tricuspid regurgitant volume
Difference in right atrium volume index
时间窗: 3 month, 1 year, 3 year
Difference in right atrium volume index between of pre- and post- operation
Difference in end-diastolic dimension
时间窗: 3 month, 1 year, 3 year
Difference in end-diastolic dimension of right ventricle between of pre- and post- operation
vtricuspid effective regurgitant oriface
时间窗: 3 month, 1 year, 3 year
tricuspid effective regurgitant oriface
square of tricuspid regurgitation
时间窗: 3 month, 1 year, 3 year
square of tricuspid regurgitation
次要结局
- major adverse cardiac events(3 month, 1 year, 3 year)
- rate of all-cause death(3 month, 1 year, 3 year)
研究者
Efremov Sergey
Deputy director for scince
Saint Petersburg State University, Russia