Mi-thos® Transcatheter Mitral Valve Replacement Study

Summary

To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

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.

Conditions2

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