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临床试验/NCT04385459
NCT04385459已完成不适用

Long Term Follow-up (=> 5 Years) for Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease

Örebro County Council1 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2018年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
346
试验地点
1
主要终点
Mortality

研究概览

简要总结

Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.

详细描述

A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.

Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.

排除标准

  • Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.

结局指标

主要结局

Mortality

时间窗: Five years.

Death after the procedure

次要结局

  • Factors associated with less favorable early and late mortality(Five years)

研究者

发起方
Örebro County Council
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ninos Samano M.D.

MD, PhD

Örebro County Council

研究点 (1)

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