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临床试验/NCT05069168
NCT05069168已完成不适用

Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve

Assiut University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
left ventricular systolic function recovery by ejection fraction

研究概览

简要总结

Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR

详细描述

Calcific aortic stenosis (AS) is the most common valve disease in the western world requiring intervention,Although Surgical Aortic Valve Replacement (SAVR) was considered as the first therapeutic method, approximately one-third of AS patients cannot undergo SAVR due to its' high risk or contraindication.

Since Transcatheter Aortic Valve Replacement (TAVR)was performed for the first time in 2002,TAVR has emerged as a growing prevalent treatment on severe symptomatic AS with the procedure initially performed on the inoperable patients with intermediate and high risks.

Recently, the Food and Drug Administration had approved it on low-risk symptomatic subjects.

AS has to be considered a disease of the left ventricle (LV) rather than purely affecting the aortic valve, Approximately one-third of patients with severe symptomatic AS have LV systolic dysfunction .

Recovery of LV ejection fraction (LVEF) is associated with improvements in clinical outcomes after TAVR as shown by a lot of studies.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with symptomatic severe aortic stenosis eligible for TAVR with LV systolic function less than 50%.

排除标准

  • Severe Rheumatic or degenerative mitral regurgitation.
  • Previous Valve Replacement.
  • Previous myocardial infarction.
  • Previous Coronary Artery By Bass Graft (CABG)Surgery.
  • Post TAVR significant paravalvular leakage

结局指标

主要结局

left ventricular systolic function recovery by ejection fraction

时间窗: 30 days post TAVR

absolute increase of ≥10% in EF compared with baseline

left ventricular systolic function recovery by STE

时间窗: 30 days post TAVR

Myocardial recovery by STE is defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline

次要结局

  • Quality of life assessment(30days post TAVR)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anwar S Helen

Principle investigator

Assiut University

研究点 (1)

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