Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Mitral regurgitation degree measure
研究概览
简要总结
The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve chordae.
详细描述
Summary: This study compares the efficacy and the safety of two surgical procedures for the treatment of mitral valve prolapse due to degeneration of the mitral valve: chordae replacement and the translocation of secondary mitral valve chordae.
In our study, researchers used the loop method proposed by von Oppel and Mohr in 2000. The main principle of the method of prosthetic chordae is the preservation of the native anatomy of the mitral valve. This principle is achieved by the implantation of artificial chordae made of ePTFE Gore-Tex threads.
The chordae replacement method essentially involves five stages:
- Measuring the required length of the chordae.
- Forming the loops.
- Fixation of the group of loops to the papillary muscles.
- Fixation of the chordal loops to the free edge of the valve.
- Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse.
Chordae translocation is the alternative method, which does not require measurement and selection of chordae lengths. Chordae replacement is technically easier (less aortic clamping time) with comparable results.
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
- Single (Participant)
盲法说明
Single blind masking (Participant)
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
- •Isolated type II mitral valve insufficiency by A. Carpentier
- •Mitral regurgitation degree >2
- •Age >18 years
- •Signed informed consent to participate in the study
排除标准
- •Any other cardiac surgeries
- •Age <18 years
- •Multiple organ failure
- •ReDo procedure
- •Persistent atrial fibrillation
- •Acute infective endocarditis
- •Refusal to sign informed consent
研究组 & 干预措施
Mitral valve chordae prosthesis
Patients of this group receive mitral valve chordae replacement performed in five stages:
- Measure the required length of the chordae.
- Forming loops.
- Fixation of the loop group to the papillary muscles.
- Fixation of chordal loops to the free edge of the valve.
- Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse.
干预措施: Mitral valve chordae prosthesis (Procedure)
Mitral valve chordae translocation
The technique of translocation of secondary chordae:
The method consists essentially of three stages:
- Selection of the secondary chordae.
- Fixation of secondary chordae to the free edge of the valve.
- Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.
干预措施: Mitral valve chordae translocation (Procedure)
结局指标
主要结局
Mitral regurgitation degree measure
时间窗: Two weeks
Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery
次要结局
- Surgical efficacy measure(One year)
- ERO measure(Two weeks)