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临床试验/NCT03290872
NCT03290872Unknown不适用

A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.

University Health Network, Toronto0 个研究点目标入组 50 人开始时间: 2017年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
Mean mitral valve gradient

研究概览

简要总结

Recently published work has suggested that mitral valve annuloplasty ring type may affect the development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and poor functional status. However, these results have not been comprehensively determined in a systematic manner on a general mitral valve repair population. As well, an underlying mechanism for these findings is not understood.

The investigators hypothesize that mitral valve repair with a complete annuloplasty ring (Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring (Simplici- T) may not necessarily result in elevated mitral gradients consistent with functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis that a correctly sized, flexible complete annuloplasty ring has detrimental effects.

As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in North America utilizes one of the many forms of complete flexible rings available, this information is urgently required.

The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and 3) the effect on patient functional capacity at 1 year.

If FMS early post repair is a real phenomenon, the investigators hope to better understand the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the mitral valvular apparatus, aortic mitral interactions and LV remodeling.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mitral regurgitation secondary to degenerative valve disease referred to Prof Tirone David (Co-investigator) will be invited to take part.
  • The mitral valve anatomy must be anatomy suitable for repair.
  • The patient must be able to perform treadmill exercise echocardiography.
  • The patient must be over 18 years of age.

排除标准

  • Any presence of life-limiting disease process, for example advanced malignancy.
  • Hemodynamically unstable patients in cardiogenic shock
  • Concomitant aortic valve disease/surgery
  • Previous mitral valve repair
  • Impaired left ventricular systolic function as defined by a left ventricular ejection fraction of ≤ 50%.
  • If the patient lives out of state or cannot attend follow up visits.

研究组 & 干预措施

Carpentier Edwards Physio 2 Complete flexible mitral ring

Active Comparator

Mitral Valve Annuloplasty Ring Repair using Carpentier Edwards Physio 2 Complete flexible mitral ring

干预措施: Carpentier Edwards Physio 2 Complete flexible mitral ring (Device)

Simplici T Partial flexible mitral annuloplasty ring

Active Comparator

Mitral Valve Annuloplasty Ring Repair using Simplici T Partial flexible mitral annuloplasty ring

干预措施: Simplici T Partial flexible mitral annuloplasty ring (Device)

结局指标

主要结局

Mean mitral valve gradient

时间窗: 1 year

Mean mitral valve gradient measured by transthoracic echocardiogram

次要结局

  • Left ventricular remodelling(1 year)
  • Aortic-mitral coupling(1 year)
  • Change in functional capacity(1 year)

研究者

申办方类型
Other
责任方
Sponsor

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