prizvalve® transcatheter atrioventricular valve replacement study

Conditions: Atrioventricular Annular Calcification; Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Summary: to evaluate the safety and performance of the prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

the prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Eligibility criteria:
1. inclusion criteria for patients with severe atrioventricular valve annular calcification: 1. atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed); 2. patient with symptoms, and nyha functional class≥ⅱ; 3. 18 years and older who is not in pregnancy or lactation; 4. life expectancy\>12 months; 5. patient who is anatomically suitable for transcatheter atrioventricular valve replacement; 6. according to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; 7. the patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups; 8. patient with high risk of routine surgery (sts\>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated. 2. inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair: 1. the patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis; 2. the patient is symptomatic with nyha functional class≥ii or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination); 3. 18 years and older who is not in pregnancy or lactation; 4. patient who is anatomically suitable for transcatheter atrioventricular valve replacement; 5. according to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; 6. the patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups; 7. patient with high risk of routine surgery (sts\>8%) or severe comorbidities that is not suitable for surgery. exclusion criteria: 1. evidence of an acute myocardial infarction \<1 month(30 days) before the intended treatment; 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 atrial fibrillation; 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 to procedure; 8. allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy; 9. active stage of infective endocarditis or other active infection; 10. cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack; 11. patient with poor compliance and could not complete the study as required.