Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 主要终点
- Freedom from significant mitral regurgitation
研究概览
简要总结
The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease
详细描述
Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.
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
- Double (Participant, Outcomes Assessor)
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
- •severe primary mitral regurgitation due to degenerative mitral valve disease
排除标准
- •previous open cardiac surgery,
- •indication for concomitant aortic valve replacement,
- •left ventricle impairment (ejection fraction < 40%).
研究组 & 干预措施
Flexible band
Mitral valve repair with flexible posterior annuloplasty band
干预措施: Mitral valve repair (Procedure)
Flexible band
Mitral valve repair with flexible posterior annuloplasty band
干预措施: Ring annuloplasty with posterior band (Device)
Complete ring
Mitral valve repair with complete rigid ring
干预措施: Mitral valve repair (Procedure)
Complete ring
Mitral valve repair with complete rigid ring
干预措施: Ring annuloplasty with complete ring (Device)
结局指标
主要结局
Freedom from significant mitral regurgitation
时间窗: 12 months
Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
次要结局
- Survival(12 months, 24 months)
- Freedom from reoperations(12 months, 24 months)
- Freedom from severe MR recurrence(12 months)