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临床试验/NCT00629902
NCT00629902已完成不适用

Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement

Florence Nightingale Hospital, Istanbul1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1

研究概览

简要总结

The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.

详细描述

Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch. The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis. Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension. Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases. However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical course of this condition.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

入选标准

  • Patients > 18 years with a clinical condition of mitral valve prosthesis

排除标准

  • Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve)
  • Concomitant aortic valve prosthesis and tricuspid valve prosthesis
  • Presence of > +2 aortic valve regurgitation and/or mild aortic stenosis
  • Prosthetic mitral valve replacement operation < 6 months
  • Left ventricular ejection fraction < 50%
  • Chronic obstructive pulmonary disease
  • Concomitant hypertrophic cardiomyopathy, atrial septal defect
  • Patients with poor ehocardiographic window

研究者

发起方
Florence Nightingale Hospital, Istanbul
申办方类型
Other

研究点 (1)

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