Evaluation of a new transcatheter mitral valve replacement device

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.

This study is testing a new heart valve replacement device to see if it can safely help people with severe mitral valve problems who can't have regular surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 122 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Shanghai NewMed Medical Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT04195984 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 and older with severe mitral valve regurgitation who are deemed high risk for open surgery.

Not a fit: Patients who have had previous mitral valve surgery or those with severe comorbidities such as untreated coronary artery disease or severe right heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe mitral valve regurgitation who are at high surgical risk.

How similar studies have performed: Other studies involving transcatheter mitral valve replacement have shown promising results, indicating that this approach may be effective for high-risk patients.

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions Mitral Valve Regurgitation