Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China

Study Overview
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Brief Summary
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To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.

Official Title
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A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process; Age ≥ 18 years old; Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation. Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV; Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System. Exclusion Criteria: Patients had any stroke/TIA within 30 days; Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging); Patients with active infection requiring antibiotic therapy; Patients with active ulcer or gastrointestinal bleeding within the past 3 months; Patients with history of coagulopathy or refuse future blood transfusion; Patients unable to undergo transesophageal echocardiography (TEE); Patients who are pregnant or breastfeeding, or planning to have children within 12 months; Patients who are unable to adhere to the follow-up schedule and complete the examination; Patients enrolled in other clinical studies and within the follow-up period; Patients with known allergies to device components or contrast agents; Patients unable to receive anticoagulant or antiplatelet therapy; Patients with a life expectancy of less than 12 months due to non-cardiac disease; Patients requiring emergency surgical treatment; Patients scheduled for cardiac surgery within 12 months; Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm); Patients with moderate or above mitral stenosis; Flail mitral leaflets, or moderate to severe mitral valve prolapse; Patients with severe hepatic or renal insufficiency; Patients with severe calcification of the mitral annulus and/or mitral leaflets; Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device; Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and/or T-MB) within the past 1 month; Patients with untreated symptomatic coronary lesions requiring revascularization; Patients with untreated severe aortic stenosis and severe aortic regurgitation; Patients with aortic valve prosthesis; Patients with severe tricuspid valve lesions requiring surgical intervention; Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly; LVEF < 30%; LVEDD > 70 mm; Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm; Hypertrophic obstructive cardiomyopathy (HOCM); Patients with active or recent (within 3 months) endocarditis; Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg) Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.

Ages Eligible for Study
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Minimum Age: 18 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: A single set of test<br>The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems. | Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System<br>* The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 12 months | All-cause mortality | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success defined as an alive patient at exit from procedure room, with all of the following: Successful vascular access, delivery and retrieval of the HighLife delivery systems Deployment and correct positioning of the HighLife 28mm bioprosthesis Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE. | Immediate after procedure | 
| Cardiac function change | NYHA functional classification | 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years | 
| Quality of life of patients | Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline. | 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years |