Aortic Stenosis,AS
Conditions
Interventions
Experimental group:Transcatheter Aortic Valve Replacement,TAVR
Sponsors
Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: To participate in the trial, patients must meet all of the following criteria: 1. Age >=70 years old; 2. Patients with severe symptomatic aortic stenosis (mean transaortic gradient >=40mmHg (1 mmHg=0.133 kPa), or transaortic velocity >=4.0m/s, or aortic valve area =II; 4. The life expectancy after prosthetic valve implantation is more than 1 year; 5. As assessed by no less than two cardiothoracic surgeons, it was recorded as contraindication for surgery or not suitable for routine surgery; 6. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to receive relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. The imaging data showed that the patient was not anatomically suitable for transcatheter aortic valve implantation; 2. Acute MI (defined as Q-wave MI or non-Q-wave MI with CK-MB= 2 times normal and/or Tn elevation (WHO definition)) within 1 month before valve implantation; 3. Any therapeutic traumatic cardiac surgery (other than coronary revascularization) within 1 month before valve implantation; 4. Prosthetic heart valve at any location, or combined with severe stenosis or severe regurgitation of other valves; 5. Bleeding constitution or coagulation dysfunction (platelet PLT<50×109/L); 6. Hemodynamic instability requiring continuous mechanical cardiac support; 7. Severe left ventricular dysfunction with left ventricular ejection fraction LVEF<20%; 8. Echocardiography showed intracardiac thrombus or vegetation; 9. Decompensated renal insufficiency (endogenous creatinine clearance <20ml/min); 10. Active peptic ulcer or upper gastrointestinal bleeding within 3 months; 11. Cerebrovascular events (CVA) within 3 months before valve implantation, excluding transient ischemic attack; 12. Allergy or contraindication to antiplatelet drugs, anticoagulant drugs, or contrast agents, resulting in the inability to use appropriate drugs before or during surgery, allergy or contraindication to polymer materials; 13. Patients with active infective endocarditis or other infections; 14. Concurrently participating in other drug or device studies; 15. The investigator determined that enrollment was not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 12-month all-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Equipment success rate;Surgical success rate;Success rate of valve retrieval;Performance of the conveying system;Recycling system performance (such as using a recycling system);Performance of developing exchange solution, curing agent, and exchange system;Valve function;Improvement in quality of life;NYHA; | — |
Countries
China
Contacts
Public ContactYingqiangGuo
West China Hospital, Sichuan University
Outcome results
None listed