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.
This study is a multicenter, single-arm, prospective clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Transcatheter Aortic Valve Replacement
Shanghai NewMed Medical Co., Ltd.
Shanghai, China
RECRUITINGComposite 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.
Time frame: 30 days after procedure
Device success rate
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).
Time frame: Immediately after procedure
Procedural success rate
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).
Time frame: 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).
Time frame: Immediately after procedure
Valve function
Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day of discharge, 30 days, 1-5 year
Incidence of permanent pacemaker implantation
Rate of patients with permanent pacemaker implantation during the trial.
Time frame: 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.
Time frame: 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.
Time frame: 1 day of discharge, 30 days, 1-5 year
Incidence of acute kidney injury
Rate of patients with acute kidney injury during the trial.
Time frame: 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).
Time frame: 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.
Time frame: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year