Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Detailed Description
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This study is a multicenter, single-arm, prospective clinical study.

Official Title
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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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Prizvalve Pro™ transcatheter aortic valve system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 years ; 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); Cardiac function NYHA ≥ II; Life expectancy> 12 months; Patients who are anatomically suitable for transcatheter aortic valve implantation; 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; 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: Acute myocardial infarction occurred within 1 month before this treatment; Congenital unicuspid aortic valve; 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); Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+); Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate; Untreated severe coronary artery stenosis that requires revascularization; Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation; Patients who need emergency surgery for any reason; Patients with hypertrophic cardiomyopathy with obstruction; Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Patients with left ventricular outflow tract obstruction; A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components; Patients who are unable to receive anticoagulation or antiplatelet therapy; Cerebrovascular accident occurred within 3 months, not including transient ischemic attack; Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc; Active infective endocarditis or other active infections; 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; The investigator judged that patient with poor compliance and could not complete the study as required.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter aortic valve replacement<br>Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system | Device: Prizvalve Pro™ transcatheter aortic valve system<br>* Transcatheter Aortic Valve Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint event rate at 30 days | Composite endpoint event includes all-cause death, stroke, myocardial infarction, permanent pacemaker implantation, serious vascular and access-related complications, surgical intervention for aortic valve reoperation, valve-in-valve surgery. | 30 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate | Device success is defined as The device enters the vascular approach, be transported, released and implanted successfully, and the delivery system is removed from the body successfully; The implanted valve achieves the desired efficacy (mean transvalvular pressure difference <20 mmHg or peak flow velocity <3 m/s in the aortic valve, no severe prosthetic aortic regurgitation or perivalvular leak). | Immediately after procedure | 
| Procedural success rate | Procedure success is defined as Implantation of ≤2 valves, with the implanted valves placed in the appropriate anatomic position; No intraoperative or immediate postoperative mortality; The intended purpose of the procedure was achieved without serious intraoperative complications (coronary occlusion, septal perforation, mitral valve damage or incompetence, pericardial tamponade, surgical termination, and open-heart surgical treatment for cardiac surgery). | Immediately after procedure | 
| Delivery system and component performance evaluation | Delivery system performance evaluation includes delivery, transvalve, release positioning, balloon filling and retrieval, visibility, and retrieval performance. (For each assessment: 1-4 points；1=excellent, 2=good, 3=fair, 4=poor). | Immediately after procedure | 
| Valve function | Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage. | Immediately after procedure, 1 day of discharge, 30 days, 1 year | 
| Improvement in cardiac function | Cardiac function is based on the New York Heart Association (NYHA) classification scheme. | 1 day of discharge, 30 days, 1-5 year | 
| Improvement in quality of life | The SF-12 rating scale is used to assess quality of life. | 30 days, 1 year | 
| Incidence of all-cause mortality | Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality. | Immediately after procedure, 1 day of discharge, 30 days, 1-5 year | 
| Incidence of myocardial infarction | Rate of patients with myocardial infarction during the trial. | Immediately after procedure, 1 day of discharge, 30 days, 1-5 year | 
| Incidence of disabling stroke | Rate of patients with disabling stroke during the trial. | 1 day of discharge, 30 days, 1-5 year | 
| Incidence of permanent pacemaker implantation | Rate of patients with permanent pacemaker implantation during the trial. | 1 day of discharge, 30 days, 1-5 year | 
| Incidence of serious vascular and access-related complications | Rate of patients with serious vascular and access-related complications during the trial. | Immediately after procedure, 1 day of discharge, 30 days, 1-5 year | 
| Incidence of serious bleeding | Rate of patients with serious bleeding during the trial. | 1 day of discharge, 30 days, 1-5 year | 
| Incidence of acute kidney injury | Rate of patients with acute kidney injury during the trial. | 1 day of discharge, 30 days, 1-5 year | 
| Incidence of major cardiovascular and cerebrovascular adverse events | Incidence of MACCE during the trial. MACCE is defined as death, stroke, myocardial infarction, arrhythmia, conduction block, and aortic valve reoperation (interventional or surgical). | 1 day of discharge, 30 days, 1-5 year | 
| Incidence of other TAVI-related complications | Rate of patients with other TAVI-related complications during the trial. Other TAVI-related complications include conversion to surgery, valve-in-valve implantation, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valvular thrombosis, valvular ectopic (migration, embolization, erroneous release), etc. | Immediately after procedure, 1 day of discharge, 30 days, 1-5 year |