Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction in procedure duration
研究概览
简要总结
The goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.
详细描述
Background: Rheumatic valvular disease, a chronic sequela of acute rheumatic fever, is a leading cause of cardiovascular mortality in developing countries. The available options of management include surgical treatment and balloon valvulotomy. Among various forms of rheumatic valvular lesions, severe mitral stenosis with favorable morphology can be successfully treated by balloon valvulotomy.
Methods: The study is a randomized controlled trial with intervention in both arms.
The objective of this study is to compare procedural time as a primary end point.
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
- •significant mitral stenosis
- •low Wilkins score (< 10)
- •mitral regurgitation grade not more than 2
排除标准
- •high Wilkins score (>10)
- •unfavourable anatomy
- •presence of left appendage thrombus
- •non-conclusive periprocedural trans oesophageal echocardiography imaging
结局指标
主要结局
Reduction in procedure duration
时间窗: day 1
procedure time in minutes
次要结局
- procedure failure(day 1)