To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);
Patient with symptoms, and NYHA Functional Class≥Ⅱ;
18 years and older who is not in pregnancy or lactation;
Life expectancy>12 months;
Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;
Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
Patient with hypertrophic cardiomyopathy with obstruction;
Shanghai NewMed Medical Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator