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.
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.
Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;
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;
Single group
the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System
DeviceThe 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.
All-cause mortality at 12 months
All-cause mortality
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.
Cardiac function change
NYHA functional classification
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.
Operative complication
The rate of operative complication
The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)
Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial
Incidence of major adverse valve-related events (MAVREs) during the trial
including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.
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Peijia Medical Technology (Suzhou) Co., Ltd.
Lead sponsor
West China Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
