Implantation of a new valve system for patients with failing heart valves

An Exploratory Study to Evaluate the Prizvalve® System in Patients With Failing Bioprosthetic Valve

This study is testing a new valve system to see if it can help people with failing heart valves who are at risk for surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai NewMed Medical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05652062 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of the Prizvalve® transcatheter valve system in patients suffering from failing bioprosthetic valves. It is a single-center, single-arm, prospective exploratory study that aims to determine if this innovative approach can provide a viable treatment option for patients who are at intermediate or higher surgical risk. Participants will undergo the valve implantation procedure and will be monitored for outcomes related to their heart function and overall health.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with moderate to severe stenosis or regurgitation of a failing bioprosthetic valve who are not suitable for traditional surgery.

Not a fit: Patients with other significant heart diseases requiring simultaneous intervention or those with a life expectancy of less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a less invasive option for patients with failing bioprosthetic valves, potentially improving their quality of life and heart function.

How similar studies have performed: While this approach is exploratory, similar transcatheter valve interventions have shown promise in treating other heart valve conditions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
2. Age≥18 years old who are not in pregnancy or lactation;
3. NYHA Function Class≥ II;
4. Patient who is anatomically suitable for the implantation of the Prizvalve® ;
5. According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
6. Heart team agrees valve implantation will likely benefit the patient;
7. Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Patients with other valvular diseases that require simultaneous intervention;
2. Patients with other heart diseases that require simultaneous intervention;
3. Estimated life expectancy \< 12 months;
4. Failing valve has moderate and above paravalvular regurgitation;
5. Failing valve in unstable ore not structurally intact;
6. Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
7. Anatomical characteristics that would preclude transcatheter valve implantation;
8. Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
9. Patient with acute myocardial infarction within 30 days;
10. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
11. Patient with hypertrophic cardiomyopathy with obstruction;
12. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
13. Patients with active infective endocarditis or other active infections;
14. Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \< 20%;
15. Patients who cannot tolerate anticoagulant or antiplatelet therapy;
16. Patients with severe untreated coronary artery stenosis requiring revascularization;
17. Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack;
18. Patients who refuse surgical treatment in emergency situations under any circumstances;
19. Patients who have severely disabled Alzheimer's disease and inability to take care of themselves;
20. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
21. The investigator judged that patient with poor compliance and could not complete the study as required.

Where this trial is running

Shanghai, Shanghai

• Zhongshan Hospital — Shanghai, Shanghai, China (Recruiting)

Conditions Failing Bioprosthetic Valve