Severe aortic stenosis
Conditions
Interventions
treatment group:Transcatheter aortic valve system therapy
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 70 years; 2. Symptomatic patients with severe aortic stenosis (effective aortic orifice area index cm2/m2, or mean cross-aortic pressure gradient 40 mmHg1 mmHg=0.133 kPa or cross-aortic flow velocity 4.0 m/s, or aortic orifice area cm2); 3. NYHA Grade II; 4. Life expectancy after implantation of the prosthetic valve is more than 1 year; 5. Patients anatomically suitable for transcatheter aortic valve implantation; 6. Patients assessed and recorded as surgical contraindications by two or more cardiothoracic surgeons, or assessed and recorded as high-risk (STS >= 8) or high-risk for routine surgery; 7. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Spontaneous acute myocardial infarction (WHO definition: Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and troponin T) occurred within 30 days prior to this treatment; 2. Patients whose aortic root anatomy and pathological changes are not suitable for artificial valve implantation; Have received any therapeutic cardiac surgery within 30 days (except cardiac stent and pacemaker implantation); 4. Complex aortic valve disease (aortic stenosis with severe regurgitation); Moderate to severe mitral stenosis; Severe mitral regurgitation; Severe tricuspid regurgitation; 5. Implanted valves anywhere in the heart; 6. Bad fluid quality of the blood system, bleeding constitution and coagulation disorders; 7. Preoperative hemodynamics were unstable and mechanical cardiac assistance was needed; 8. Emergency surgery is required for any reason; 9. Obstructive hypertrophic cardiomyopathy; 10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF)Severe right ventricular dysfunction; 12. Echocardiography suggests the presence of intracardiac mass, thrombus or vegetations; 13. Active peptic ulcer; 14. Allergic to nickel-titanium alloys, cattle products, PET polyethylene terephthalate (PEG) or contrast agents; Can not tolerate anticoagulant, antiplatelet therapy; 15. Congenital aortic valve malformation (except bicuspid valve); A cerebrovascular event (CVA) occurred within 3 months, including hemorrhagic stroke; 17. Renal dysfunction decompensation (endogenous creatinine clearance rate ml/min); 18. Vascular disease affecting device approach 19. Active infective endocarditis or other active infections; 20. Participated in clinical trials of other drugs or medical devices before inclusion, and the time limit of the main study endpoint has not been reached; 21. The researcher judged that patients had poor compliance and could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate success rate of instruments after surgery;Cumulative all-cause mortality at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate of instruments after surgery;Conveyor system recovery success rate (recovery time);achievement ratio of operation;Valvular function was performed at 30 days, 6 months, 12 months, and 2-5 years after surgery;Cardiac function improved before discharge, 30 days after surgery, 6 months, 12 months, and 2-5 years;Quality of life improved before discharge, 30 days after surgery, 6 months, 12 months, and 2-5 years;All cause mortality immediately after surgery, 30 days after surgery, 6 months after surgery, and 2-5 years after surgery;Incidence of major unconscience-related cerebrovascular events (MACCE) immediately after surgery, 30 days after surgery, 6 months, 12 months after surgery, and 2-5 years after surgery;Incidence of life-threatening or disabling bleeding and severe bleeding immediately, 30 days, 6 months, 12 months, and 2 to 5 years after surgery;Incidence of permanent pacemaker implantation immediately after surgery, 30 days after surgery, 6 months, 12 months, and 2-5 years after surgery;The incidence of severe vascular complications immediately after surgery and 30 days after surgery;The incidence of other TAVI-related complications immediately after surgery, 30 days after surgery, 6 months, 12 months after surgery, and 2-5 years after surgery; | — |
Countries
china
Contacts
Public ContactYong Peng
West China Hospital, Sichuan University
Outcome results
None listed