Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Trial Parameters
Brief 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.
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. Congen