Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)

Study Overview
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Brief Summary
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To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.

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

Official Title
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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(First-in-Man Study)

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Mi-thos® Transcatheter Mitral Valve Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe mitral regurgitation ≥ 3+; Patients with an STS score >8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery; Age ≥ 65 years old; Life expectancy > 12 months; 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; Life expectancy < 12 months; Patients with severe thoracic deformities.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | All of the following must be present: I. Absence of procedural mortality; and II. Successful access, delivery, and retrieval of the device delivery system; and III. Successful deployment and correct positioning of the first intended device; and IV. Freedom from emergency surgery or reintervention related to the device or access procedure | immediate post-surgical | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality | All-cause mortality after TMVR | 30 days | 
| Rate of Severe adverse event | Severe adverse events rate after TMVR | 30 days | 
| Device success | All of the following must be present: I. Absence of procedural mortality or stroke; and II. Proper placement and positioning of the device; and III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and IV. Continued intended safety and performance of the device, including: A. No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Significant alterations in mitral valve hemodynamics (MR≤moderate/EOA≥ 1.5 cm2/mean transmitral gradient < 5 mmHg/no paravalvular MR associated hemolysis) | 30 days | 
| Procedural success | All of the following must be present: I. Device success, and II. Absence of major device or procedure related serious adverse events, including: A. Death B. Stroke C. Life-threatening bleeding (MVARC scale) D. Major vascular complications E. Major cardiac structural complications F. Stage 2 or 3 acute kidney injury (includes new dialysis) G. Myocardial infarction or coronary ischaemia requiring PCI or CABG H. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention | 30 days | 
| Incidence of arrhythmia or conduction block | Incidence of arrhythmia or conduction block after TMVR | 30 days |