NCT02536703Unknown3 期
LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis 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 20 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Combined rate of death from any cause, myocardial infarction, and stroke
研究概览
简要总结
To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)
- •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.
- •Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.
- •Life expectancy is less than one year
结局指标
主要结局
Combined rate of death from any cause, myocardial infarction, and stroke
时间窗: 30 days following procedure
Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)
次要结局
- Number of participants with procedural complications(30 days following procedure)
- Quality of Life (SF-12)(6 months following procedure)
- Functional status (NYHA-classification)(6 months following procedure)
- Echocardiographic prosthesis status(6 months following procedure)
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
研究点 (1)
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