Mi-thos® Transcatheter Mitral Valve Replacement Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

Detailed Description
-----------------
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.

Official Title
-----------------
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.

Conditions
-----------------
Mitral Valve Regurgitation

Intervention / Treatment
-----------------
* Device: Mi-thos® valve and transapical delivery system


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system | Device: Mi-thos® valve and transapical delivery system<br>* Transcatheter mitral valve replacement system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality | All-cause mortality after TMVR | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality | All-cause mortality after TMVR | 30 days, 6months, 2-5 years | 
| Severe adverse event rate | Severe adverse events rate after TMVR | 30 days, 6months, 1 year, 2-5 years | 
| NYHA Heart Function Rating | NYHA Heart Function Rating after TMVR | 30 days, 6months, 1 year, 2-5 years | 
| Kansas City Cardiomyopathy score | Kansas City Cardiomyopathy score after TMVR | 30 days, 6months, 1 year, 2-5 years |