severe aortic stenosis and aortic valve insufficiency
Conditions
Interventions
1:Interventional prosthetic valve replacement
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. signed written informed consent; 2. aged =18 years; 3. manifestations of disease due to aortic stenosis and / or regurgitation caused, and New York Heart Association functional class NYHA= II; 4. At least one Heart intervention doctor and two cardiovascular surgeon diagnosis: traditional open heart valve replacement surgery is contraindications for the patient [defined as the risk of death within 30 days postoperative > 50%, there are serious irreversible complications or other factors affecting the operation, such as severe ascending aorta and aortic valve calcification, physical fragility, chest deformity, severe liver disease, severe lung disease, etc.] or high risk of surgery (LogEuroSCORE = 20% and / or STS = 8); 5. At least one heart intervention physician and two cardiovascular surgeons believe that implantation of the valve may benefit the patient; 6. severe aortic stenosis, echocardiography results show that: the average cross valve pressure gradient = 40 mm Hg, or aortic flow velocity=4.0 m / s, aortic prosthetic valve area 19mm and <29mm,measured by heart CT measurement; 2. ascending aorta diameter <50mm measured at sinus tube junction.
Exclusion criteria
Exclusion criteria: 1. patients infected or suspected infection; 2. previous history of endocarditis or active endocarditis; 3. Occurrence of acute myocardial infarction within30 days (Q wave MI, non-Q wave MI with the increase of muscle Acid kinase isoenzyme, troponin T); 4. echocardiography showed any intracranial mass, left ventricular or atrial thrombus, neoplasm; 5. suffering from uncontrolled atrial fibrillation; 6. Hypertrophic cardiomyopathy; 7. Mitral or tricuspid valve insufficiency (regurgitation grade II or more); 8. Previously received aortic valve transplants (mechanical valve or biological valve stent); 9. Known allergy to the contrast Agents, aspirin, heparin, ticlopidine, nickel-titanium memory alloy or pig product allergies; 10. It is known that all anticoagulation regimens are taboo or allergic, or anticoagulants can not be used during the test; 11. One of the following is known (based on the assessment from the screening to the day of surgery): 1) other serious diseases that may cause life expectancy reduce to less than 12 months (such as clinical recurrence or metastasis of cancer, congestive heart failure, etc.); 2) There are currently drug abuse problems (eg alcohol, cocaine, heroin, etc.); 3) plan to accept surgery that may cause confusion or lack of understanding of the data. 12. A history of cerebrovascular accident (CVA) or CT-confirmed clear transient cerebral ischemia (TIA) over the past 6 months; 13. Patients with total neck or internal carotid artery or vertebral artery stenosis (>70%); 14. white blood cell count 2.5 mg/dL (221 umo/L); 20. Have a bleeding tendency or a history of blood clotting or refusing blood transfusion; 21. Active gastric ulcer or active gastrointestinal (GI) bleeding; 22. Nervous system diseases with serious influence on the ability of action and daily life; 23. severe dementia; 24. Any cause of emergency surgery; 25. Participating in clinical studies of other research drugs or devices; 26. Patients with pregnant or planned pregnancies, or who are taking estrogen or estrogen-like drugs (suspected pregnant women must have negative serum or urine tests for human chorionic gonadotropins before being included in the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Carotid ultrasound;Aortic angiography;Echocardiography;Cardiac Output;Cardiac CT;Blood routine examination;Coagulation test;liver function;Renal function; | — |
Countries
China
Contacts
Public ContactXiaoke Shang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed