Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Prizvalve Pro™ transcatheter aortic valve system

• Registration Number: NCT05864456
• Lead Sponsor: Shanghai NewMed Medical Co., Ltd.

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-18
• Study Start: 2023-07-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter aortic valve replacement	Prizvalve Pro™ transcatheter aortic valve system	Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system

Primary Outcome Measures

Name	Time	Method
Composite endpoint event rate at 30 days	30 days after procedure	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.

Secondary Outcome Measures

Name	Time	Method
Device success rate	Immediately after procedure	Device success is defined as; 1. The device enters the vascular approach, be transported, released and implanted successfully, and the delivery system is removed from the body successfully; 2. 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).
Improvement in cardiac function	1 day of discharge, 30 days, 1-5 year	Cardiac function is based on the New York Heart Association (NYHA) classification scheme.
Incidence of myocardial infarction	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year	Rate of patients with myocardial infarction during the trial.
Incidence of disabling stroke	1 day of discharge, 30 days, 1-5 year	Rate of patients with disabling stroke during the trial.
Procedural success rate	Immediately after procedure	Procedure success is defined as; 1. Implantation of ≤2 valves, with the implanted valves placed in the appropriate anatomic position; 2. No intraoperative or immediate postoperative mortality; 3. 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).
Delivery system and component performance evaluation	Immediately after procedure	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).
Valve function	Immediately after procedure, 1 day of discharge, 30 days, 1 year	Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.
Improvement in quality of life	30 days, 1 year	The SF-12 rating scale is used to assess quality of life.
Incidence of serious vascular and access-related complications	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year	Rate of patients with serious vascular and access-related complications during the trial.
Incidence of acute kidney injury	1 day of discharge, 30 days, 1-5 year	Rate of patients with acute kidney injury during the trial.
Incidence of other TAVI-related complications	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year	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.
Incidence of all-cause mortality	Immediately after procedure, 1 day of discharge, 30 days, 1-5 year	Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality.
Incidence of permanent pacemaker implantation	1 day of discharge, 30 days, 1-5 year	Rate of patients with permanent pacemaker implantation during the trial.
Incidence of serious bleeding	1 day of discharge, 30 days, 1-5 year	Rate of patients with serious bleeding during the trial.
Incidence of major cardiovascular and cerebrovascular adverse events	1 day of discharge, 30 days, 1-5 year	Incidence of MACCE during the trial. MACCE is defined as death, stroke, myocardial infarction, arrhythmia, conduction block, and aortic valve reoperation (interventional or surgical).

Trial Locations

Locations (1)

Shanghai NewMed Medical Co., Ltd.; 🇨🇳 Shanghai, China