Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

1. Inclusion criteria for patients with severe atrioventricular valve annularcalcification:
2. Atrioventricular valve annular calcification with moderate or severe atrioventricularvalve disease (stenosis, regurgitation, or mixed);
3. Patient with symptoms, and NYHA Functional Class≥Ⅱ;
4. 18 years and older who is not in pregnancy or lactation;
5. Life expectancy>12 months;
6. Patient who is anatomically suitable for transcatheter atrioventricular valvereplacement;
7. According to the evaluation of the heart team, the patient can benefit fromtranscatheter atrioventricular valve replacement;
8. The patient can understand the purpose of the trial, voluntarily participate in andsign the informed consent form, and is willing to accept relevant examinations andclinical follow-ups;
9. Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is notsuitable for surgery, or with severely calcified valve annulus that cannot beoperated.
10. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulusrepair:
11. The patient has undergone atrioventricular valve replacement or valve annulus repairin the past, accompanied by severe atrioventricular valve regurgitation or stenosis;
12. The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiringblood transfusion (no other causes of hemolytic anemia were found after examination);
13. 18 years and older who is not in pregnancy or lactation;
14. Patient who is anatomically suitable for transcatheter atrioventricular valvereplacement;
15. According to the evaluation of the heart team, the patient can benefit fromtranscatheter atrioventricular valve replacement;
16. The patient can understand the purpose of the trial, voluntarily participate in andsign the informed consent form, and is willing to accept relevant examinations andclinical follow-ups;
17. Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is notsuitable for surgery.

Exclusion criteria:

1. Evidence of an acute myocardial infarction <1 month(30 days) before the intendedtreatment;
2. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation)is performed within 30 days of the index procedure;
3. Patient with planned concomitant surgical or transcatheter ablation for atrialfibrillation;
4. Patient with hypertrophic cardiomyopathy with obstruction;
5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;
6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
7. Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior toprocedure;
8. Allergy to cobalt-chromium alloy or contrast agent; inability to tolerateanticoagulation and antiplatelet therapy;
9. Active stage of infective endocarditis or other active infection;
10. Cerebrovascular accident within 3 months prior to procedure, excluding transientischemic attack;
11. Patient with poor compliance and could not complete the study as required.