NCT07060183撤回不适用
Aortic Valve Replacement for Moderate Aortic Stenosis With Left Ventricular Decompensation Early Feasibility Study
Dermed Diagnostics, Inc.0 个研究点开始时间: 2027年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Composite rates of all-cause mortality or morbidity
研究概览
简要总结
Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation.
详细描述
Single-center prospective study. Subjects with moderate aortic stenosis and left ventricular decompensation will receive aortic valve replacement by the Ross procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate aortic stenosis, defined by transthoracic echocardiograph
- •Max aortic velocity less than 4.0 m/sec.
- •Mean aortic gradient less than 40.0 mmHg.
- •1.0 cm2 < Aortic Valve Area < 1.5 cm
- •Left ventricular decompensation
排除标准
- •Not suitable for the Ross procedure.
- •Documented history of cardiac amyloidosis.
研究组 & 干预措施
Intervention
Experimental
Aortic Valve Replacement
干预措施: Ross procedure (Procedure)
Control
No Intervention
No intervention
结局指标
主要结局
Composite rates of all-cause mortality or morbidity
时间窗: 12 months
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to procedure-related complication, or valve dysfunction requiring reintervention.
次要结局
- Left ventricular compensation(12 months)
研究者
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