NCT05275088招募中不适用
An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
详细描述
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Technical success
时间窗: 30 days
Definition: 1. Freedom from death; 2. Successful vascular delivery and retrieval of transcatheter valve delivery system; 3. Correct position of transcatheter valve; 4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); 5. Adequate performance of prosthesis (mean pressure gradient (MVG) \<10mmHg, valve regurgitation \<2+).
次要结局
- All-cause mortality(30 days,1 year)
- Device success(30 days,1 year)
- Procedural Success(30 days,1 year)
研究者
研究点 (1)
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