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;
Single group
Prizvalve® system
DeviceTranscatheter atrioventricular valve replacement
Technical success
Definition: 1. Freedom from death; 2. Successful vascular delivery and retrieval of transcatheter valve delivery system; 3. Correct position of transcatheter valve; 4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); 5. Adequate performance of prosthesis (mean pressure gradient (MVG) \<10mmHg, valve regurgitation \<2+).
Procedural Success
1. Device success; 2. No SAE's including: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.
Device success
Definitions: 1. Freedom from stroke; 2. Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis); 3. No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related); 4. No atrioventricular valve stenosis (mean pressure gradient \<10mmHg); 5. Atrioventricular valve regurgitation \<2+ (including central leakage and paravalvular leakage), and no related hemolysis; 6. LVOT pressure gradient increased \<20mmHg.
All-cause mortality
All-cause mortality included cardiac and non-cardiac death.
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Shanghai NewMed Medical Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
