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临床试验/NCT05044377
NCT05044377Unknown不适用

Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease

Yongjian Wu1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
540
试验地点
1
主要终点
all-cause mortality

研究概览

简要总结

Aortic valve disease (AVD) is the most common and age-related mortality in elderly patients with valvular heart disease (VHD). Although transcatheter aortic valve replacement (TAVR) has been recommended at a higher level in foreign guidelines, there are still many high-risk and severe elderly patients with VHD who have not received effective treatment because of many complications and untimely medical treatment. Different from Europe and the United States, the majority of patients with bicuspid aortic valve are in China, and the calcification is more serious. The current clinical evaluation system and treatment guidelines can not be effectively applied to the high-risk and complex elderly patients. Therefore, the investigators should train and set up a valvular heart disease team, explore the technical difficulties of TAVR treatment in such patients, establish emergency TAVR operation mechanism, build a clinical evaluation system for high-risk and complex elderly patients with aortic valve disease in China, evaluate the curative effect periodically and further optimize the treatment strategy, so as to improve the quality of life and the meaning of life cycle of elderly patients with VHD in China Great significance.

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • • patients over 75 years old meet one of the following conditions. severe valvular heart disease as defined by echocardiography:
  • aortic stenosis, moderate or above, or valve area ≤1.0cm2, or maximal jet velocity ≥4.0m/sec, or mean pressure gradient ≥40mmHg,
  • aortic regurgitation, moderate or above, or jet width ≥65% of left ventricular outflow tract, or regurgitant volume≥60ml/beat, or regurgitant fraction ≥50%,

排除标准

  • • Patients cannot be followed up for any reasons.
  • •Patients have been enrolled in this study

结局指标

主要结局

all-cause mortality

时间窗: 1 year

The primary endpoint of this study is 1 years all-cause mortality all stroke and re-hospitalization (for valve-related decompensation or procedure-related complications) .

次要结局

未报告次要终点

研究者

发起方
Yongjian Wu
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Yongjian Wu

Chief physician

China National Center for Cardiovascular Diseases

研究点 (1)

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