Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

• Inclusion criteria for patients with severe atrioventricular valve annular calcification:

• 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;
• Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
• According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
• 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;
• 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.

• Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair:

• The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;
• 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);
• 18 years and older who is not in pregnancy or lactation;
• Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
• According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
• 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;
• Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery.

Exclusion criteria

• 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;
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;
• Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;
• Active stage of infective endocarditis or other active infection;
• Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;
• Patient with poor compliance and could not complete the study as required.