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Mi-thos® Transcatheter Mitral Valve Replacement Study

RecruitingNAAges 65 Years - anyAllShanghai NewMed Medical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Mi-thos® valve and transapical delivery system
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Where

3 sites
Fuwai hospital
Beijing, China
Zhongshan Hospital
Shanghai, China
Xijing hospital
Xi’an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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