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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006880
Receipt No. R000006017
Scientific Title Trans-catheter aortic valve implantation
Date of disclosure of the study information 2011/12/12
Last modified on 2011/12/12

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Basic information
Public title Trans-catheter aortic valve implantation
Acronym Trans-catheter aortic valve implantation
Scientific Title Trans-catheter aortic valve implantation
Scientific Title:Acronym Trans-catheter aortic valve implantation
Region
Japan

Condition
Condition Severe aortic valve stenosis
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess the safety and efficacy of trans-catheter aortic valve implantation for Japanese patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of heart failure symptom more than 1 grade in NYHA classification at 6 postoperative month
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
Interventions/Control_1 Edwards SAPIEN Transcatheter Heart Valve
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. severe aortic valve stenosis with mean pressure gradient more than 40mmHg, or velocity more than 4.0m/sec, or aortic valve area less than 0.8cm2.
2. heart failure symptom with NYHA classification greater than class II.
3. STS score >10. or patients who have high risk for operative mortality or are 'non-operable' as determined by Cardiologist or Cardiovascular Surgeon.
Key exclusion criteria 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 30 days (or intervention with drug eluting stent within 6 months)
5.prior valve surgery with artifical valve, ring. or severe mitral valve regurgitation greater than 3+/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
10.obstructive cardiomyopathy
11. severe LV dysfunction (LVEF<20%)
12. cardiac tumor, thrombus, vegetation in UCG
13. active gastrointestinal bleeding or history of upper gastrointestinal bleeding within 3 month
14. allergy of aspirin, heparin, ticropigin, contrast medium.
15. aortic valve annulus less than 16mm or larger than 24mm
16. CVA or TIA within 6 months
17. life expectancy less than 12 months by non-cardiac disease
18. involvement to another clinical trial
19. inappropriate another factors (judged by cardiologist or cardiovascular surgeon)
Target sample size 53

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sawa Yoshiki
Organization Osaka University Graduate School of Medicine
Division name Cardiovascular Surgery, Cardiology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Surgery, Department of Cardiology
Zip code
Address
TEL 06-6879-3154
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of medicine
Department of Cardiovascular Surgery, Department of Cardiology
Institute
Department

Funding Source
Organization Osaka University Graduate School of medicine
Department of Cardiovascular Surgery
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 12 Month 12 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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 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
2011 Year 12 Month 12 Day
Last modified on
2011 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006017

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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