Aortic Valve Stenosis
Conditions
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.
Interventions
DEVICEPrizvalve Pro™ transcatheter aortic valve system
Transcatheter Aortic Valve Replacement
Sponsors
The General Hospital of Northern Theater Command
West China Hospital
Shanghai NewMed Medical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 cardiac function | 1 day of discharge, 30 days, 1-5 year | Cardiac function is based on the New York Heart Association (NYHA) classification scheme. |
| Improvement in quality of life | 30 days, 1 year | The SF-12 rating scale is used to assess quality of life. |
| 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 myocardial infarction | Immediately after procedure, 1 day of discharge, 30 days, 1-5 year | Rate of patients with myocardial infarction during the trial. |
| 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). |
| 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 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 serious bleeding | 1 day of discharge, 30 days, 1-5 year | Rate of patients with serious bleeding 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 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). |
| 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 disabling stroke | 1 day of discharge, 30 days, 1-5 year | Rate of patients with disabling stroke during the trial. |
Countries
China
Contacts
Primary ContactChunyang Wang
Backup ContactXuyang Xie
Outcome results
None listed