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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009224
Receipt No. R000010835
Scientific Title Transcatheter aortic valve replacement for patients with aortic valve stenosis
Date of disclosure of the study information 2012/11/01
Last modified on 2015/10/30

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Basic information
Public title Transcatheter aortic valve replacement for patients with aortic valve stenosis
Acronym Transcatheter aortic valve replacement
Scientific Title Transcatheter aortic valve replacement for patients with aortic valve stenosis
Scientific Title:Acronym Transcatheter aortic valve replacement
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 transcatheter aortic valve replacement
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 symptoms more than 1 grade in the NYHA classification at the 6th 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.Patients who have high risk for operative mortality or are 'non- operable' as determined by cardiologist and cardiovascular surgeon
2.Severe aortic valve stenosis with the mean pressure gradient more than 40 mmHg, velocity more than 4.0 m/sec, or aortic valve area less than 0.8 cm2 by ultrasound cardiography
3.Heart failure symptoms with the NYHA classification greater than class II
4.Patient or substitute decision-maker signed the written informed consent, which had been approved by the institutional review board or its equivalence
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 2 weeks
5. Prior valve surgery with artifical valve ring or severe mitral valve regurgitation with level 3 or 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 or nonobstructive cardiomyopathy
11. Severe LV dysfunction (LVEF<20%)
12. Cardiac tumor, thrombus, vegetation in UCG
13. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months
14. Allergy to aspirin, heparin, ticropigin, or contrast medium
15. Aortic valve annulus smaller than 16 mm or larger than 25 mm
16. CVA or TIA within 1 month
17. Life expectancy less than 12 months due to non-cardiac disease
18. Involvement in another clinical trial
19. Active bacterial endocarditis or other active infections
20. Massive calcified cusp of aortic valve close to the coronary ostium
21. Allergy to cobalt-chromium alloy
22. Abdominal or thoracic aortic aneurysm or atheroma (diameters more than 5 cm ), and serious denaturation or anatomical features of thoracoabdominal aorta
23. Severe calcification, extreme tortuosity and vessel diameter less than 6.5 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuaki Mitsudo
Organization Kurashiki Central Hospital
Division name Heart Disease Center
Zip code
Address 1-1-1, Miya, Kurashiki, Okayama
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Kurashiki Central Hospital
Division name Department of Cardiology, Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kurashiki Central Hospital
Department of Cardiology
Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization Kurashiki Central Hospital
Department of Cardiology
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 倉敷中央病院 心臓病センタ- 循環器内科 心臓血管外科

Other administrative information
Date of disclosure of the study information
2012 Year 11 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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 06 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
2012 Year 10 Month 30 Day
Last modified on
2015 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010835

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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