Aortic stenosis
Conditions
Interventions
experimental group:procedure
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 70; Or 65 years =6 years. 2. Severe aortic stenosis: ultrasonic echocardiography showed a cross aortic valve flow velocity >= 4.0 m/s, or a cross aortic valve pressure difference >= 40 mmHg (1 mmHg=0.133 kPa), or an aortic valve area < 1.0 cm2, or an effective aortic valve area index < 0.6cm2/m2; Patients with low flow rate or poor low pressure were assessed by dobutamine stress test and judged to have severe aortic valve stenosis. 3. Symptoms due to aortic stenosis. 4. New York Heart Association (NYHA) Cardiac function grade II or above. 5. It has been assessed and recorded as contraindicated by two or more cardiovascular surgeons, or as high risk of surgery or high risk of conventional surgery. 6. Able to understand the purpose of the study, willing to participate in and sign informed consent, willing to accept relevant examination and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction (defined as Q wave myocardial infarction, or non-Q wave myocardial infarction, accompanied by CK-MB >= twice normal and/or Tn elevation (WHO definition)) within 1 month before this treatment; 2. Imaging data showed that the aortic root anatomy and lesions were not suitable for prosthetic valve implantation. 3. Any therapeutic traumatic cardiac surgery (except coronary revascularization, pacemaker implantation) within 30 days prior to valve implantation; 4. Ascending aortic aneurysm diameter greater than 50 mm. 5. Combined with severe stenosis or severe insufficiency of other valves; 6. Bleeding constitution or coagulation dysfunction (platelet PLT < 50 x 10^9/L); 7. Hemodynamic instability requiring continuous mechanical cardiac assistance; 8. Hypertrophic cardiomyopathy with obstruction. 9. Severe left ventricular dysfunction, LVEF < 20%; 10. Echocardiography revealed the presence of intracardiac masses, thrombi, or vegetations. 11. Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months; 12. allergic to nitinol, contrast agent, or can not tolerate anticoagulation, antiplatelet therapy; 13. Congenital unicuspid aortic valve. 14. The anatomy is not suitable for transapical aortic valve implantation. 15. Expected survival time after corrective treatment of AS is less than 12 months. 16. Cerebrovascular accident within 3 months, excluding transient ischemic attack; 17. End-stage renal disease requires long-term dialysis. 18. Active phase of infective endocarditis. 19. Participated in other drug or medical device clinical trials before enrollment has not yet reached the main study endpoint time limit; 20. The investigator judges that the patient has poor compliance and cannot complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative success rate;Operative successful rate;Recovery system performance;Valve function;Quality of life improved;Cardiac function improved; | — |
Countries
China
Contacts
Public ContactGuo Yingqiang
West China Hospital of Sichuan University
Outcome results
None listed