Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve - Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018398

Enrollment

Registered

2015-08-01

Start date

2014-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failing bioprosthetic Valve

Interventions

Valve-in-Valve procedure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. At least 1 surgeon and 1 cardiologist that the patient was not a suitable candidate for surgery because of comorbidities Aortic bioprosthesis 2-A. AVA<=1.0 (or AVAI <=0.5) or 2-B. severe regurgitation or 2-C. AVA<=1.5 and >=moderate valve regurgitation Mitral bioprosthesis 2-D. valve area <=1.0 or 2-E. severe regurgitation or 2-F. valve area <=1.5 and >=moderate valve regurgitation 3. NYHA class 3 (if not, then agreement was required from at least 1 surgeon and 1 cardiologist) 4. all patients provided written informed consent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
grade I <= Improvement in NYHA classification	—

Countries

Japan

Contacts

Public ContactKoichi Maeda

Osaka University Graduate School of Medicine Department of Cardiovascular Surgery

k-maeda@surg1.med.osaka-u.ac.jp06-6879-3154

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026