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临床试验/NCT04418960
NCT04418960Unknown不适用

Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Change in anatomical structures by MRI

研究概览

简要总结

Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •identified Barlow disease suffering from significant mitral insufficiency with indication to surgery

排除标准

  • •Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease
  • •Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia)
  • •Pregnancy
  • •Inability to give consent

结局指标

主要结局

Change in anatomical structures by MRI

时间窗: The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.

Change in anatomical structures by MRI: distance (mm) between the mitral annulus and the cardiac apex during the cardiac cycle before and after surgical correction

次要结局

  • function of the mitral valve by echocardiography(during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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