Mi-thos® Transcatheter Mitral Valve Replacement Study
Mi-thos® Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos®
 Transcatheter Delivery System.
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance
 clinical study.
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.