prizvalve pro™ transcatheter aortic valve replacement study

Conditions: Aortic Valve Stenosis

Summary: the purpose of this clinical trial is to evaluate the safety and efficacy of the prizvalve pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

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

Eligibility criteria:
inclusion criteria: 1. age ≥ 65 years ; 2. 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); 3. cardiac function nyha ≥ ii; 4. life expectancy\> 12 months; 5. patients who are anatomically suitable for transcatheter aortic valve implantation; 6. 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; 7. 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: 1. acute myocardial infarction occurred within 1 month before this treatment; 2. congenital unicuspid aortic valve; 3. 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); 4. patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\>3+); 5. patients with hematologic disorders or abnormalities that make surgical treatment inappropriate; 6. untreated severe coronary artery stenosis that requires revascularization; 7. patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation; 8. patients who need emergency surgery for any reason; 9. patients with hypertrophic cardiomyopathy with obstruction; 10. severe left ventricular dysfunction, left ventricular ejection fraction (lvef) \<20%; 11. echocardiographic evidence of intracardiac mass, thrombus or vegetation; 12. patients with left ventricular outflow tract obstruction; 13. a history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; 14. patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components; 15. patients who are unable to receive anticoagulation or antiplatelet therapy; 16. cerebrovascular accident occurred within 3 months, not including transient ischemic attack; 17. severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc; 18. active infective endocarditis or other active infections; 19. 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; 20. the investigator judged that patient with poor compliance and could not complete the study as required.