NCT05784337已完成不适用
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(First-in-Man Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.
详细描述
The Mi-thos® study is a 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 regurgitation ≥ 3+;
- •Patients with an STS score >8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery;
- •Age ≥ 65 years old;
- •Life expectancy > 12 months;
- •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;
- •Life expectancy < 12 months;
- •Patients with severe thoracic deformities.
结局指标
主要结局
Technical success
时间窗: immediate post-surgical
All of the following must be present: I. Absence of procedural mortality; and II. Successful access, delivery, and retrieval of the device delivery system; and III. Successful deployment and correct positioning of the first intended device; and IV. Freedom from emergency surgery or reintervention related to the device or access procedure
次要结局
- Rate of all-cause mortality(30 days)
- Device success(30 days)
- Procedural success(30 days)
- Incidence of arrhythmia or conduction block(30 days)
- Rate of Severe adverse event(30 days)
研究者
研究点 (2)
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