Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Incidence of more than mild tricuspid insufficiency
研究概览
简要总结
Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.
详细描述
The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.
A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.
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
- 是
入选标准
- •patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
排除标准
- •presence of pacemaker lead through the tricuspid valve
- •acute endocarditis
- •minimally invasive approach
- •Functional mitral valve insufficiency
研究组 & 干预措施
Tricuspid annuloplasty
Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery
干预措施: Tricuspid annuloplasty (Procedure)
No Tricuspid annuloplasty
Control patients
结局指标
主要结局
Incidence of more than mild tricuspid insufficiency
时间窗: 5 year
次要结局
- VO2 max(1 year)
- Right ventricular function(5 year)
研究者
Pettinari Matteo
Principal Investigator
Université Catholique de Louvain
