UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Title of the study (Brief title)	Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Region	Japan

Condition
Condition	Failing bioprosthetic Valve
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the efficacy and safety of transcatheter valve-in-valve implantation for failing bioprosthetic valve in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	grade I <= Improvement in NYHA classification
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Valve-in-Valve procedure
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	5

Research contact person
Name of lead principal investigator	Yoshi Sawa
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Surgery
Address	2-2 Yamadaoka Suita Osaka
TEL	06-6879-3154
Email	sawasec@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	Koichi Maeda
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Surgery
Address	2-2 Yamadaoka Suita Osaka
TEL	06-6879-3154
Homepage URL
Email	k-maeda@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Edwards Lifescience
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021110