跳至主要内容
临床试验/NCT05439863
NCT05439863招募中不适用

Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
all-cause death during follow-up

研究概览

简要总结

Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.

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

入选标准

  • Clinical diagnosis of severe aortic stenosis or aortic regurgitation
  • Patients undergo transcatheter aortic valve replacement

排除标准

  • patients refuse the clinical follow-up

结局指标

主要结局

all-cause death during follow-up

时间窗: 5 years

all-cause death during 5-year follow-up

次要结局

  • cardiac death during follow-up(5 years)

研究者

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

Junjie Zhang

Vice chief

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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