Replacement of damaged heart valves using the Prizvalve® system

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

This study is testing a new heart valve replacement system to see if it can help high-risk patients with severe valve problems who can't have regular surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai NewMed Medical Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05275088 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and performance of the Prizvalve® system in patients suffering from severe atrioventricular annular calcification or failed prosthetic atrioventricular valve repairs. It is a single-center, single-arm, prospective exploratory study designed to assess how well this innovative valve replacement system works in high-risk patients who are not suitable for traditional surgery. Participants will undergo the procedure and be monitored for outcomes related to valve function and overall health.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with severe atrioventricular valve disease and high surgical risk due to comorbidities.

Not a fit: Patients who are not experiencing significant symptoms or have a life expectancy of less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a less invasive option for patients with severe heart valve issues, improving their quality of life and survival rates.

How similar studies have performed: While the Prizvalve® system represents a novel approach, similar transcatheter valve replacement methods have shown promise in other studies.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

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