Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

This study is a multicenter, single-arm, prospective clinical study.

Inclusion criteria

• Age ≥ 65 years ;
• Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm², or AVA <0.5cm² /m²);
• Cardiac function NYHA ≥ II;
• Life expectancy> 12 months;
• Patients who are anatomically suitable for transcatheter aortic valve implantation;
• Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
• Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.

Exclusion criteria

• Acute myocardial infarction occurred within 1 month before this treatment;
• Congenital unicuspid aortic valve;
• Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
• Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);
• Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
• Untreated severe coronary artery stenosis that requires revascularization;
• Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
• Patients who need emergency surgery for any reason;
• Patients with hypertrophic cardiomyopathy with obstruction;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Patients with left ventricular outflow tract obstruction;
• A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
• Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
• Patients who are unable to receive anticoagulation or antiplatelet therapy;
• Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
• Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
• Active infective endocarditis or other active infections;
• Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
• The investigator judged that patient with poor compliance and could not complete the study as required.