Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Freedom from prosthetic endocarditis
研究概览
简要总结
The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis 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 clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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 40%
结局指标
主要结局
Freedom from prosthetic endocarditis
时间窗: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from prosthetic endocarditis (n,%)
Mortality
时间窗: 30-day period after surgery
Freedom from all-cause mortality (%)
Stroke
时间窗: 30-day period after surgery
Stroke rate (n,%)
Freedom from reoperation
时间窗: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)
Severe valve dysfunction
时间窗: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)
New pacemaker implantation
时间窗: 1-year after surgery, annually, assessed up to 3 years
Number of patients, free from pacemaker implantation after surgery (n,%)
次要结局
- Transvalvular gradient(1 year after surgery, annually, assessed up to 3 years)
- Transprosthetic regurgitation(1 year after surgery, annually, assessed up to 3 years)
- Right atrial remodeling(1 year after surgery, annually, assessed up to 3 years)
研究者
Mikhail Nuzhdin
Director
Chelyabinsk Regional Clinical Hospital