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临床试验/NCT06041308
NCT06041308招募中不适用

Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2021年3月16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
30,000
试验地点
1
主要终点
all-cause mortality

研究概览

简要总结

In this study, the investigators aim to use data identified through the hospital's integrated medical database and National Health Insurance database to explore the long-term performance and benefits of biological and mechanical valves. This research aims to provide more recommendations and references for valve replacement in different patient populations.

详细描述

Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most commonly discussed indicator. The choice of valves has evolved over the past 30 years, offering two options: biological valves and mechanical valves. Biological valves have seen advancements in the last 15 years, including new processes and improved valve preservation methods. The question of whether these new process valves offer better long-term effectiveness has become a hot research topic in recent years.

Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects, abnormal clotting function, and bleeding. Biological valves, on the other hand, do not require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment. However, the risk of biological valve degeneration results in an average lifespan of 10 to 20 years, which cannot match the durability of mechanical valves. This is the drawback of using biological valves.

Therefore, the investigators hope to utilize the hospital's integrated medical database and the long-term National Health Insurance database for tracking. The investigators aim to observe valve performance in different patient groups, such as young people, the elderly, patients on dialysis, those with rheumatic autoimmune diseases, and those taking specific medications, among others.

研究设计

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

入排标准

年龄范围
— 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • This is a retrospective study, and we plan to utilize data from the hospital's integrated medical database and the National Health Insurance database from January 2007 to December
  • We will identify all patients within the data who were diagnosed with valve diseases and underwent valve replacement surgery.

排除标准

  • Individuals under 20 years of age.

结局指标

主要结局

all-cause mortality

时间窗: 1998-2019

included estimated survival using a Cox regression model. Survival data were obtained for all NHIRD databases. Operative mortality was defined as death during the index hospitalization or within 30 days of the operation. Long-term survival data included death from all causes. survival outcome was measured months after the index operation.

次要结局

  • composite outcome and individual component of major adverse prosthesis-related events, including death, major bleeding, ischemic stroke, endocarditis, and aortic valve reoperation(1998-2019)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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