NCT02803294招募中4 期
THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 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 safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
详细描述
Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic aortic stenosis/regurgitation
- •Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- •The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
- •Patients are technical and anatomical eligible for interventions
排除标准
- •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
- •Subject refuses a blood transfusion.
- •Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
- •Life expectancy is less than one year
结局指标
主要结局
Death from any cause
时间窗: 1 year
次要结局
- death from cardiac causes(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- bleeding events(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- transcatheter valve failure(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- stroke(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- repeated hospitalization(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years)
- vascular complications(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years)
- changes in ascending aorta diameter(1 year,2 years, 3 years, 4 years, 5 years，10 years)
- Death from all causes(30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- device success(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- myocardial infarction(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- acute kidney injury(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- Functional Improvement from baseline per New York Heart Association functional classification(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
- permanent pacemaker implantation(30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years)
研究者
Jian'an Wang,MD,PhD
President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (1)
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