NCT00584116已完成不适用
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- aortic annulus size
研究概览
简要总结
Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age 18 years or older
- •Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.
- •Severe AS: aortic valve area (AVA) ≤ 1.0 cm2
- •Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS
排除标准
- •Emergent surgical aortic valve replacement.
- •Inability to undergo TTE or TEE intra-operatively.
- •Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
结局指标
主要结局
aortic annulus size
时间窗: 2 months
Show the correlation between the size of the aortic annulus measured intra-operatively with surgical rings (gold standard) with other methods of aortic annulus measurement that would not require surgical intervention (CT, TEE, TTE)
次要结局
未报告次要终点
研究者
研究点 (1)
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