Evaluation of a new transcatheter mitral valve replacement device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and performance of the Mi-thos® Mitral Heart Valve using a transapical delivery system in patients with severe mitral valve regurgitation. It is a multicenter, single-arm, prospective study designed to assess the outcomes of this innovative valve replacement approach. The study aims to enroll patients who are at high surgical risk and are not candidates for traditional open-heart surgery. Participants will be monitored for safety and effectiveness following the procedure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Xijing hospital
  Xi’an, Shanxi, China Recruiting

Study contacts

• Principal investigator: Wang chunsheng, Chief — Shanghai Zhongshan Hospital
• Study coordinator: Wang chunyang, CRA
• Email: cywang@newmed.cn
• Phone: (86)-21-20788668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.