Aortic Valve Stenosis
Conditions
Interventions
Sponsors
General Hospital of Northern Theater Command
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint event rate at 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate ;Procedural success rate;Delivery system and component performance evaluation;Valve function ;improvement in cardiac function;improvement in quality of life ;all-cause mortality ;Incidence of myocardial infarction ;Incidence of disabling stroke ;Incidence of permanent pacemaker implantation;Incidence of serious vascular and access-related complications;Incidence of serious bleeding;Incidence of acute kidney injury ;Incidence of major cardiovascular and cerebrovascular adverse events;Incidence of other TAVI-related complications ; | — |
Countries
China
Contacts
Public ContactXu Kai / Chen Mao
General Hospital of Northern Theater Command; West China Hospital
Outcome results
None listed