The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- prosthetic complications
研究概览
简要总结
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality
详细描述
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality. Antithrombotic therapy after new biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery is assessed by six-minute walking test and plasma BNP level.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;
- •o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)
- •mitral valve disease requiring surgical disease
排除标准
- •the need for prosthetics of two or more valves
- •patients with a decrease in LVEF of less than 45%;
- •the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
- •high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
- •the diameter of the ascending aorta is more than 45 mm;
- •unwillingness of the patient to participate in the study.
研究组 & 干预措施
bioprosthesis
prosthetics of heart valves with dentures "MedEng-Bio"
干预措施: valve prosthetics (Procedure)
结局指标
主要结局
prosthetic complications
时间窗: 10 years after surgery
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
death
时间窗: 10 years after surgery
death from any cause
次要结局
未报告次要终点
研究者
Boris N. Kozlov
Professor
Tomsk National Research Medical Center of the Russian Academy of Sciences