Mi-thos® Transcatheter Mitral Valve Replacement Study

Shanghai NewMed Medical

Status

Enrolling

Conditions

Mitral Valve Regurgitation

Treatments

Device: Mi-thos® valve and transapical delivery system

Study type

Interventional

Funder types

Industry

Identifiers

M-valve-2018-06

Details and patient eligibility

About

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

Full description

The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.

Enrollment

122 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.