Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair

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.

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.