Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
Exclusion Criteria:
- presence of pacemaker lead through the tricuspid valve
- acute endocarditis
- minimally invasive approach
- Functional mitral valve insufficiency
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Tricuspid annuloplasty
Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery
|
Tricuspid annuloplasty
|
|
无干预：No Tricuspid annuloplasty
Control patients
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence of more than mild tricuspid insufficiency
大体时间：5 year
|
5 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
VO2 max
大体时间：1 year
|
Physical function capacity measured by VO2 max
|
1 year
|
|
Right ventricular function
大体时间：5 year
|
Right ventricle function at the follow up
|
5 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Tricuspid annuloplasty的临床试验
-
CorMatrix Cardiovascular, Inc.Yale University招聘中
-
The First Affiliated Hospital with Nanjing Medical...尚未招聘心脏衰竭 | 典型心房扑动