Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- combination of all-cause mortality or heart failure hospitalisation
研究概览
简要总结
De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.
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
- •Scheduled for mitral valve surgery
- •Tricuspid Annular diameter > 40mm or >21mm/m²
排除标准
- •Tricuspid Regurgitation more than 2+
- •Unable to provide informed consent
结局指标
主要结局
combination of all-cause mortality or heart failure hospitalisation
时间窗: at 12 months post-surgery
次要结局
- Duration of Hospital and ICU stay(postoperative phase)
- progressive TR > 2+ post-surgery(3, 6, 12 and 18 months)
- Quality of Life(6, 12 and 18 months)
- cardiovascular mortality(at 3, 6, 12 and 18 months post-surgery)
- RV function & geometry(3, 6, 12 and 18 months)
- All-Cause Mortality(at 3, 6, 12 and 18 months post-surgery)
- Hospitalization for Heart Failure(at 3, 6, 12 and 18 months post-surgery)
- Exercise Tolerance(6, 12 and 18 months)
研究者
Wilfried Mullens, MD PhD
Professor Cardiovascular Physiology
Hasselt University