RecruitingNot ApplicableNCT04195984

Mi-thos® Transcatheter Mitral Valve Replacement Study

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.

Sponsor

Shanghai NewMed Medical Co., Ltd.

Enrollment

122 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Mitral Valve Regurgitation

Summary

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

Eligibility

Min Age: 65 Years

Inclusion Criteria6

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 Criteria18

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.