Overview
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Description
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.