UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006880 |
|---|---|
| Receipt number | R000006017 |
| Scientific Title | Trans-catheter aortic valve implantation |
| Date of disclosure of the study information | 2011/12/12 |
| Last modified on | 2011/12/12 21:32:42 |
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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
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
Sponsor or person
Institute
Osaka University Graduate School of medicine
Department of Cardiovascular Surgery, Department of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006017
