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临床试验/NCT06722066
NCT06722066招募中不适用

Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: Scientific Association of Interventional Cardiology - Transcatheter Aortic Valve Replacement (SAINT-TAVR) Calcium Registry

Eunpyeong St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:

Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?

Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.

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

入选标准

  • Adults aged 19 years or older.
  • Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis.
  • Individuals who have voluntarily provided written informed consent to participate.

排除标准

  • Individuals who have not provided written informed consent for this study.

结局指标

主要结局

All-cause mortality

时间窗: 3 years follow-up

次要结局

  • Hospitalization for heart failure(3 years follow-up)
  • Stroke(3 years follow-up)
  • Myocardial infarction(3 years follow-up)
  • Permanent pacemaker insertion(3 years follow-up)
  • Vascular complication(30 days follow-up)

研究者

发起方
Eunpyeong St. Mary's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osung Kwon

Assistant professor

Eunpyeong St. Mary's Hospital

研究点 (1)

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