NCT03163329尚未招募2 期
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement
China National Center for Cardiovascular Diseases0 个研究点目标入组 300 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- All-cause mortality, all stroke, and re-hospitalization
研究概览
简要总结
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Severe, calcific bicuspid aortic stenosis.
- •Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
排除标准
- •Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
- •Severe aortic regurgitation (>3+).
- •Severe mitral regurgitation (>3+).
研究组 & 干预措施
TAVR group
Experimental
干预措施: TAVR (Procedure)
SAVR group
Active Comparator
干预措施: SAVR (Procedure)
结局指标
主要结局
All-cause mortality, all stroke, and re-hospitalization
时间窗: 1 year post procedure
This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%
次要结局
未报告次要终点
研究者
Yongjian Wu
Clinical Professor
China National Center for Cardiovascular Diseases
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