Severe Aortic Valve Stenosis and/or Regurgitation
Conditions
Interventions
Single cohort :Using J-Valve system
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 95 Years
Inclusion criteria
Inclusion criteria: CI1. Sign the letter of consent; CI2. Age >=18-years; CI3. Shows disease caused by aortic stenosis and/or regurgitation, with NYHA>=II; CI4. At least one cardiovascular specialist and two cardiovascular surgeons diagnose that: subjects are tabooed with traditional opening heart valve replacement surgery (which is defined as the risk of death during 30days after surgery is more than 50% or existing severe irreversible complications or other factors affecting the surgery (such as ascending aorta and severe aortic valve calcification, fragile physique, chest deformity, severe liver disease, severe lung disease, etc.)) or high-risk surgery (LogEuroSCORE=20% and/or STS=8); CI5. At least one cardiovascular specialist and two cardiovascular surgeons believe that the patient will benefit from valve implantation. CI6. Severe aortic stenosis and/or regurgitation, echocardiography results showing average pressure >=40 mm Hg, or aortic blood flow peak flow >=4.0 m/s, or aortic prosthetic valve area 19 mm and <29 mm, confirmed by CT measurement; AI 2 Ascending aortic diameter <43 mm in diameter, as referenced with the sinotubular junction.
Exclusion criteria
Exclusion criteria: CE1. Infected patients or suspected infected persons; CE2. Past history of or active endocarditis endocarditis; CE3. Acute myocarditis within the past 30 days. (Q-wave MI, or non-Q-wave MI associated with creatine kinase isoenzyme, troponin T rise); CE4. Any cardiac mass, left ventricular or atrial thrombus found by echocardiogram; CE5. Uncontrolled atrial fibrillation; CE6. Familial hypertrophic cardiomyopathy; CE7. Mitral or tricuspid valvular insufficiency (regurgitation greater then II); CE8. Previously undergone aortic graft (mechanical valve or biological valve stent); CE9. Known allergy for contrast agents, aspirin, heparin, ticlopidine, nitinol or porcine products; CE10. Known contraindication or allergies to anti-coagulants, or if anti-coagulants are unable to be used during the study; CE11. Any participants with the following conditions (from the time of screening to the day of surgery): a) Other diseases that may reduce life expectancy to less than 12 months (cancer, congestive heart failure, etc.); b) Drug abuse (alcohol, cocaine, heroin, etc.); c) Plans to undergo surgery that may result in non-compliance with the study or cause confusion in data interpretation; CE12. Cerebrovascular accident (CVA) within the past six months; CE13. Suffering from symptomatic carotid or vertebral artery stenosis (>70%) of the patients. CE14. Leukocyte count 2.5 mg/dL (221µmoI/L); CE20. Has a history of bleeding tendencies or clotting disorders or refuses blood transfusions. CE21. Active ulcer or gastrointestinal (GI) bleeding; CE22. Severe neurological disorders affecting daily life CE23. Severe dementia; CE24. Any reason needs emergency operation; CE25. Taking part in clinical research studies of drugs or other devices; CE26. Pregnant or planning pregnancy or patients taking estrogen or estrogen-like drugs (enrolled patients who may be pregnant suspected of pregnant women must test negative for serum and urine human chorionic gonadotropin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality;Cardiovascular related mortality;Function of J-Valve after implantation;J-Valve related complication; | — |
Countries
China
Contacts
Public ContactShi Yingkang
Outcome results
None listed