Mi-thos® Transcatheter Mitral Valve Replacement Study

Launched by SHANGHAI NEWMED MEDICAL CO., LTD. · Dec 10, 2019

Keywords

ClinConnect Summary

The Mi-thos® Transcatheter Mitral Valve Replacement Study is a clinical trial designed to test a new heart valve and delivery system for patients with severe mitral valve regurgitation, a condition where the heart's mitral valve does not close properly, causing blood to leak backward. This study is currently looking for participants who are at least 65 years old and have a high risk for traditional surgery. To be eligible, participants must have been evaluated by a team of heart specialists and determined to not be candidates for open-heart surgery.

If you join this trial, you will be receiving the Mi-thos® Mitral Heart Valve through a less invasive method, which means you may not need major surgery. Participants will be closely monitored for their safety and the performance of the valve. It’s important to note that certain medical conditions, such as severe heart failure or recent strokes, may disqualify someone from participating. This study is an opportunity to help improve treatment options for people with serious heart valve issues.

Gender

ALL

Eligibility criteria

• 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.