NCT06196684进行中（未招募）不适用
Early Safety and Clinical Efficacy of Mitral Allografts in Patients With Primary Tricuspid Valve Disease Scheduled for Tricuspid Valve Replacement
Chelyabinsk Regional Clinical Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mortality (all cause and valve-related)
研究概览
简要总结
The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.
详细描述
Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
- •Intraoperative findings suggested for tricuspid valve replacement rather than repair.
排除标准
- •Pregnancy
- •Confirmed active drug addiction
- •Progressive HIV-infection
- •HIV-infected patients with CD4-cells count less than 250
- •Patients with secondary tricuspid valve pathology (left-sided valve disease)
- •LV Ejection fraction less than 50%
结局指标
主要结局
Mortality (all cause and valve-related)
时间窗: 30-day period
Estimate rate of mortality (all cause and valve-related)
次要结局
- Cardiac structural complications(30 days)
- Acute kidney injury(30 days)
- Allograft valve dysfunction(30 days)
- Neurologic events(30-day period)
- Bleeding and transfusions(30 days)
研究者
Mikhail Nuzhdin
Director
Chelyabinsk Regional Clinical Hospital
研究点 (1)
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