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

Shanghai NewMed Medical Co., Ltd.1 site in 1 country73 target enrollmentJuly 5, 2023

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Shanghai NewMed Medical Co., Ltd.
Enrollment: 73
Locations: 1
Primary Endpoint: Composite endpoint event rate at 30 days
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 5, 2023

End Date

May 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai NewMed Medical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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%;

Outcomes

Primary Outcomes

Composite endpoint event rate at 30 days

Time Frame: 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 Outcomes

Device success rate(Immediately after procedure)
Improvement in cardiac function(1 day of discharge, 30 days, 1-5 year)
Incidence of myocardial infarction(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
Incidence of disabling stroke(1 day of discharge, 30 days, 1-5 year)
Procedural success rate(Immediately after procedure)
Delivery system and component performance evaluation(Immediately after procedure)
Valve function(Immediately after procedure, 1 day of discharge, 30 days, 1 year)
Improvement in quality of life(30 days, 1 year)
Incidence of serious vascular and access-related complications(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
Incidence of acute kidney injury(1 day of discharge, 30 days, 1-5 year)
Incidence of other TAVI-related complications(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
Incidence of all-cause mortality(Immediately after procedure, 1 day of discharge, 30 days, 1-5 year)
Incidence of permanent pacemaker implantation(1 day of discharge, 30 days, 1-5 year)
Incidence of serious bleeding(1 day of discharge, 30 days, 1-5 year)
Incidence of major cardiovascular and cerebrovascular adverse events(1 day of discharge, 30 days, 1-5 year)