Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Aortic Valve Stenosis
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility Criteria
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.
Sites / Locations
- Shanghai NewMed Medical Co., Ltd.
Arms of the Study
Arm 1
Experimental
Transcatheter aortic valve replacement
Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system