A multicenter trial to assess transcatheter aortic valve replacement for chronic hemodialysis patients with aortic valve stenosis
- Conditions
- Severe aortic valve stenosis Chronic kidney disease (hemodialysis patients)
- Registration Number
- JPRN-UMIN000012426
- Lead Sponsor
- Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital Heart Disease Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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 for any reason 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 18 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 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of heart failure symptoms more than 1 grade in the NYHA classification at the postoperative 1st year
- Secondary Outcome Measures
Name Time Method