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临床试验/NCT02195102
NCT02195102Unknown不适用

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY

Michael Kang-Yin Lee, MD10 个研究点 分布在 8 个国家目标入组 2,000 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
10
主要终点
Death from any cause

研究概览

简要总结

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

排除标准

  • 未提供

结局指标

主要结局

Death from any cause

时间窗: 5 years

次要结局

  • Death from cardiac cause(5 years)
  • Stroke(5 years)
  • Myocardial infarction(5 years)
  • Repeat hospitalization(5 years)
  • Acute kidney injury(5 years)
  • Vascular complication(5 years)
  • Bleeding events(5 years)
  • Device success(5 years)

研究者

发起方
Michael Kang-Yin Lee, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Kang-Yin Lee, MD

MD

Queen Elizabeth Hospital, Hong Kong

研究点 (10)

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相似试验

The Asian Pacific TAVR Multicenter Registry | 临床试验