Severe aortic valve stenosis
Conditions
Interventions
Sponsors
Kurashiki Central Hospital Department of Cardiology Department of Cardiovascular Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who have high risk for operative mortality or are 'non- operable' as determined by cardiologist and cardiovascular surgeon 2.Severe aortic valve stenosis with the mean pressure gradient more than 40 mmHg, velocity more than 4.0 m/sec, or aortic valve area less than 0.8 cm2 by ultrasound cardiography 3.Heart failure symptoms with the NYHA classification greater than class II 4.Patient or substitute decision-maker signed the written informed consent, which had been approved by the institutional review board or its equivalence
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 2 weeks 5. Prior valve surgery with artifical valve ring or severe mitral valve regurgitation with level 3 or 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 or nonobstructive cardiomyopathy 11. Severe LV dysfunction (LVEF<20%) 12. Cardiac tumor, thrombus, vegetation in UCG 13. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months 14. Allergy to aspirin, heparin, ticropigin, or contrast medium 15. Aortic valve annulus smaller than 16 mm or larger than 25 mm 16. CVA or TIA within 1 month 17. Life expectancy less than 12 months due to non-cardiac disease 18. Involvement in another clinical trial 19. Active bacterial endocarditis or other active infections 20. Massive calcified cusp of aortic valve close to the coronary ostium 21. Allergy to cobalt-chromium alloy 22. Abdominal or thoracic aortic aneurysm or atheroma (diameters more than 5 cm ), and serious denaturation or anatomical features of thoracoabdominal aorta 23. Severe calcification, extreme tortuosity and vessel diameter less than 6.5 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of heart failure symptoms more than 1 grade in the NYHA classification at the 6th postoperative month | — |
Countries
Japan
Outcome results
None listed