Severe aortic valve stenosis
Conditions
Interventions
Sponsors
Osaka University Graduate School of medicine Department of Cardiovascular Surgery, Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. severe aortic valve stenosis with mean pressure gradient more than 40mmHg, or velocity more than 4.0m/sec, or aortic valve area less than 0.8cm2. 2. heart failure symptom with NYHA classification greater than class II. 3. STS score >10. or patients who have high risk for operative mortality or are 'non-operable' as determined by Cardiologist or Cardiovascular Surgeon.
Exclusion criteria
Exclusion criteria: 1. acute myocardial infarction within 1 month 2. unicuspid, bicuspid aortic valve, or aortic valve stenosis without calcification 3. severe aortic valve regurgitation 4. cardiac intervention within 30 days (or intervention with drug eluting stent within 6 months) 5.prior valve surgery with artifical valve, ring. or severe mitral valve regurgitation greater than 3+/4. 6.leukopenia, acute anemia,thrombocytopenic purpura. or past history of coagulation disorder. 7.coronary artery disease with significant stenosis requiring intervention. 8. unstable circulation requiring mechanical support 9.emergency procedure 10.obstructive cardiomyopathy 11. severe LV dysfunction (LVEF<20%) 12. cardiac tumor, thrombus, vegetation in UCG 13. active gastrointestinal bleeding or history of upper gastrointestinal bleeding within 3 month 14. allergy of aspirin, heparin, ticropigin, contrast medium. 15. aortic valve annulus less than 16mm or larger than 24mm 16. CVA or TIA within 6 months 17. life expectancy less than 12 months by non-cardiac disease 18. involvement to another clinical trial 19. inappropriate another factors (judged by cardiologist or cardiovascular surgeon)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of heart failure symptom more than 1 grade in NYHA classification at 6 postoperative month | — |
Countries
Japan
Outcome results
None listed