NCT05595226招募中不适用
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
Sheng Liu1 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2021年12月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
研究概览
简要总结
The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value 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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
- •Informed consent was obtained
排除标准
- •Re-operation of mitral regurgitation
- •Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries.
- •Mitral valve replacement
- •Unable to undergo TEE
结局指标
主要结局
Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
时间窗: 1 year
mitral valve repair failure, 1-year reoccurrence of mitral regurgitation
次要结局
- The incidence of secondary transfer, perioperative complications(1 year)
- Intraoperative conditions including extracorporeal circulation time, aortic occlusion time(1 year)
- The recurrence rate of residual mitral valve regurgitation(1 year)
- Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation(1 year)
研究者
Sheng Liu
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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