Multi-centre Randomised Trial Investigating the Effect of PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus on Tricuspid Regurgitation Progression, Right Ventricular Remodeling and Functional Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Progression of TR
研究概览
简要总结
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.
详细描述
The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 20 to 40 patients over a 12-month enrolment period.
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1 month (phone contact), 6 month and 1-year after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2 BSA) at preoperative echocardiography and fulfilling the following selection criteria:
- •Inclusion criteria:
- •Written informed consent
- •Degenerative mitral valve disease
- •> 18 years old
排除标准
- •Main exclusion criteria:
- •Presence of structural or organic tricuspid valve disease
- •urgent operation
- •presence of pacemaker leads through the tricuspid annulus
- •acute endocarditis or other organic valve diseases
- •previous surgical procedure
- •Associated cardiac procedure
- •NYHA class IV
- •Severe COPD (GOLD class 3,4)
结局指标
主要结局
Progression of TR
时间窗: 1 year
Progression of TR at one year follow-up defined as worsening of at least one class with respect to pre-surgery as assessed by the Core lab evaluation of the echocardiogram.
次要结局
- Evaluation of reverse right ventricle (RV) remodelling(1 year)
- Residual TR(1 year)