NCT03466918已完成不适用
Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population
Edwards Lifesciences4 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年5月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- All-cause Mortality
研究概览
简要总结
To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.
详细描述
Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study.
A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤
- •If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team.
- •Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.
- •NYHA Functional Class II or greater.
- •The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site.
- •The study patient agrees to comply with all required postprocedure follow-up visits.
排除标准
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
- •Aortic valve is a congenital unicuspid or is non-calcified.
- •Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0).
- •Anomalous coronary artery that would interfere with proper placement of the valve.
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
结局指标
主要结局
All-cause Mortality
时间窗: 30-days
All of the deaths that occurred in this population regardless of the cause.
次要结局
- Cardiovascular Mortality(30-days)
- Number of Participants With a Stroke(30-days)
- Non-Cardiovascular Mortality(30-days)
研究者
研究点 (4)
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