NCT07116551进行中（未招募）不适用
Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 8
- 主要终点
- Technical success
研究概览
简要总结
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
详细描述
The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve 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
- Device Feasibility
- 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
- 是
入选标准
- •Subject is at least 18 years of age
- •Subject is able and willing to return for required follow-up visits and assessments
- •Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria
排除标准
- •Pregnant or nursing subjects
- •Life expectancy for a condition other than aortic stenosis is less than 2 years
- •Presence of other anatomic or comorbid conditions
- •Incapacitated individuals
- •Evidence of an acute myocardial infarction
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Liver failure
- •Severe mitral regurgitation or severe mitral stenosis
研究组 & 干预措施
BE TAVI System
Experimental
BE TAVI System
干预措施: Abbott BE TAVI System (Device)
结局指标
主要结局
Technical success
时间窗: From start of procedure up to end of procedure
Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.
Device success
时间窗: 30 days
Intended performance of the valve
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
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