aortic regurgitation
Conditions
Interventions
Intervention group:Operative treatment
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =65 years old; 2. Symptomatic moderate to severe aortic regurgitation; 3. New York Heart Association cardiac function Grade NYHA= II; 4. As judged by the cardiac team not suitable for surgical treatment or high risk/contraindication of surgery, the recommended reference criteria are: STS score =8 for surgical valve replacement or =6 for surgical repair, or other risk factors: If there are =2 indicators of moderate to severe weakness or possible surgical impairment or =2 major organ dysfunction that cannot be improved after surgery or other surgical risk factors determined by the cardiac team; 5. The aortic valve anatomy was evaluated as suitable for transcatheter aortic valve replacement. 6. Subjects voluntarily participate in this study and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Active endocarditis; 2. Acute myocardial infarction within 30 days or coronary revascularization within 30 days; 3. Cerebrovascular accident (CVA) within the past 30 days; 4. Echocardiography found any intracardiac mass, left ventricle or atrium thrombus, or growth; Obstructive hypertrophic cardiomyopathy; 5.Obstructive hypertrophic cardiomyopathy; 6. Other valvular diseases requiring serious surgical intervention; 7. Previous aortic valve graft (mechanical or biological); 8. Known allergy to contrast media, nickel-titanium memory alloy or bovine products; 9. Known contraindications or allergies to all anticoagulant regimens, or inability to use anticoagulants during testing; 10. Other serious diseases that may reduce life expectancy to less than 12 months; 11. There is currently a problem of drug abuse (e.g., cocaine, heroin, etc.). 12. Severe left ventricular dysfunction, left ventricular ejection fraction < 20%; 13. Is receiving dialysis treatment; 14. People with severe dementia; 15. Participating in clinical studies of other investigational drugs or devices (if the investigational product participating in a trial is already on the market, extended follow-up for marketed products is eligible); 16. Persons who are pregnant or planning to become pregnant; 17. Other patients deemed unsuitable for this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 month cumulative all-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of operation;Improvement of cardiac function;Evaluation of quality of life; Major cardiovascular and cerebrovascular adverse events in 12 months after surgery;Incidence of adverse events in 12 months after surgery;Serious adverse events occur in 12 months after surgery; | — |
Countries
China
Contacts
Public ContactGuo Yingqiang
West China Hospital, Sichuan University
Outcome results
None listed