Evaluation of a new transcatheter valve for severe aortic stenosis

Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk

This study is testing a new heart valve procedure for people with severe aortic stenosis who can't have regular surgery to see if it can safely improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 73 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Shanghai NewMed Medical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05864456 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in patients with severe aortic valve stenosis who are at high risk for surgery or unsuitable for conventional surgical options. It is a multicenter, single-arm, prospective study that aims to provide an alternative treatment for these patients. Participants will undergo the procedure and be monitored for outcomes related to valve performance and patient health. The study will include comprehensive assessments to ensure the valve's effectiveness and safety.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 and older with symptomatic severe aortic valve stenosis who are deemed unsuitable for traditional surgery.

Not a fit: Patients who have had an acute myocardial infarction within the last month or those with other significant comorbidities may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have shown success with transcatheter aortic valve replacement approaches, indicating a promising avenue for patients with similar conditions.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 65 years ;
2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm², or AVA \<0.5cm² /m²);
3. Cardiac function NYHA ≥ II;
4. Life expectancy\> 12 months;
5. Patients who are anatomically suitable for transcatheter aortic valve implantation;
6. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
7. Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Acute myocardial infarction occurred within 1 month before this treatment;
2. Congenital unicuspid aortic valve;
3. Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\>3+);
5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
6. Untreated severe coronary artery stenosis that requires revascularization;
7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
8. Patients who need emergency surgery for any reason;
9. Patients with hypertrophic cardiomyopathy with obstruction;
10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
12. Patients with left ventricular outflow tract obstruction;
13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
15. Patients who are unable to receive anticoagulation or antiplatelet therapy;
16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
18. Active infective endocarditis or other active infections;
19. 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;
20. The investigator judged that patient with poor compliance and could not complete the study as required.

Where this trial is running

Shanghai

• Shanghai NewMed Medical Co., Ltd. — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Mao Chen, Professor — coordinating investigator
• Study coordinator: Chunyang Wang

Conditions Aortic Valve Stenosis