To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Technical success — 30 days 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+).
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai NewMed Medical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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