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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018398
Receipt No. R000021110
Scientific Title Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Date of disclosure of the study information 2015/08/01
Last modified on 2018/12/27

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Basic information
Public title Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Acronym Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Scientific Title Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshi Sawa
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 2-2 Yamadaoka Suita Osaka
TEL 06-6879-3154
Email sawasec@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Maeda
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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