NCT04195984招募中不适用
Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Freedom from all-cause mortality
研究概览
简要总结
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
详细描述
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe mitral valve regurgitation ≥ 3+;
- •High surgical risk fot open mitral valve surgery;
- •Age ≥ 65 years old;
- •Life expectancy > 12 months;
- •As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
- •Patients sign an informed consent form.
排除标准
- •Previous cardiac mitral valve surgery;
- •Active infections requiring antibiotic therapy;
- •Clinically significant untreated Coronary Artery Disease (CAD);
- •Pulmonary hypertension （Pulmonary systolic pressure > 70 mmHg）;
- •Patients with severe right heart failure;
- •Left ventricular ejection fraction <25%;
- •Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
- •Dialysis patient;
- •Patients with severe coagulopathy;
- •Patients with contraindications to anticoagulant drugs;
- •Patients with stroke or transient ischemic within 30 days;
- •Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
- •Patients who require surgery or interventional therapy for other valvular lesions;
- •Patients with severe macrovascular disease requiring surgical treatment;
- •Patients with more than 70% of carotid stenosis;
- •To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
- •Patients with severe neurological disorders affecting cognitive ability;
- •Patients with severe thoracic deformities.
结局指标
主要结局
Freedom from all-cause mortality
时间窗: 1 year
All-cause mortality after TMVR
次要结局
- Freedom from all-cause mortality(30 days, 6months, 2-5 years)
- Severe adverse event rate(30 days, 6months, 1 year, 2-5 years)
- Kansas City Cardiomyopathy score(30 days, 6months, 1 year, 2-5 years)
- NYHA Heart Function Rating(30 days, 6months, 1 year, 2-5 years)
研究者
研究点 (3)
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