Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
- Conditions
- Failing bioprosthetic Valve
- Registration Number
- JPRN-UMIN000018398
- Lead Sponsor
- Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
1. history of coronary infarction within previous 1 month 2. PCI or PTA within previous 1 month 3-1. WBC<1000 3-2. Plt<50000 3-3. history of coagulation disorder 3-4. hyper coagulability state 4. untreated coronary artery disease requiring revascularization 5. cardiac shock or state requiring mechanical support 6. emergent operation 7. EF <20% 8. CVA or TIA within previous 1 month 9. active gastrointestinal bleeding 10. 1 Aspirin, 2 ticlopidine hydrochloride, 3 heparin, 4 contrast agents, 5 Nitinol was contraindication. 11. active endocarditis 12. refusal of blood transfusion 13. life expectancy less than 12 months due to associated non-cardiac comorbid condition 14. severe dementia 15. participation of other clinical trial 16. carotid or vertebral artery stenosis with symptoms 17. Heart team is not agree regarding medical, social, or psychological state 18. at least 1 cardiovascular surgeon and 1 cardiologist are not agree regarding anatomical findings. 19. HCM 20. presence of vegetation 21. HOCM 22. potential of coronary obstruction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method