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;
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