NCT07082426进行中（未招募）不适用
EASE Study: Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
适应症
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
- 8
- 试验地点
- 3
- 主要终点
- Technical Success
研究概览
简要总结
Early System Experience with the Abbott Balloon-expandable TAVI System
详细描述
The Early System Experience with the Abbott's balloon-expandable TAVI System first-in-human study ('EASE study') will evaluate preliminary clinical evidence on the safety and feasibility of the Abbott's balloon-expandable 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
- 否
入选标准
- •Increased surgical risk
- •Appropriate anatomy
- •At least 18 years of age
- •Willing to return for follow-up assessments
排除标准
- •Pregnant or nursing subjects
- •Anatomic or comorbid conditions
- •Evidence of acute myocardial infarction
- •Inoperable/ineligible for surgery
- •Renal disease requiring chronic dialysis
研究组 & 干预措施
Balloon expandable TAVI
Experimental
干预措施: Balloon expandable TAVI (Device)
结局指标
主要结局
Technical Success
时间窗: Post 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 (3)
Loading locations...
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