Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Improvement in severity of FTR
研究概览
简要总结
This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.
详细描述
Functional Tricuspid regurgitation (FTR) occurs due to annular dilatation in association with left sided valve disease and is more commonly seen than primary pathology in patients with Rheumatic mitral valve disease. FTR occurs due to increased right ventricle after load that leads to either dilatation or geometric deformation of Tricuspid annulus. If left untreated, FTR may worsen and increase morbidity and mortality.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants will be all patients between 15 to 75 years of age group diagnosed as a case of Rheumatic Mitral Valve disease with moderate to severe functional Tricuspid regurgitation.
排除标准
- •Patient with organic Tricuspid Valve (TV) lesion diagnosed in Echocardiography
- •Patient with FTR requiring Mitral Valve repair
- •Patient with FTR requiring concomitant aortic valve replacement
- •Patient with FTR secondary to pathology other than Mitral valve disease
结局指标
主要结局
Improvement in severity of FTR
时间窗: within 3 months
Definitions: 1. Improvement in FTR: refers to Mild or No TR 2. Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area i. \<5cm2 = Mild ii. 6-10cm2 = Moderate iii. \>10cm2 = Severe
次要结局
- Mortality(up to 3 months of intervention)
研究者
Marisha Aryal
Resident, Cardiac Surgery Dept.
Shahid Gangalal National Heart Centre