跳至主要内容
临床试验/NCT03604484
NCT03604484已完成不适用

Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Université Catholique de Louvain0 个研究点目标入组 106 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery

干预措施: Tricuspid annuloplasty (Procedure)

No Tricuspid annuloplasty

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pettinari Matteo

Principal Investigator

Université Catholique de Louvain

相似试验