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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010629
Receipt No. R000012371
Scientific Title Percutaneous transvenous aortic valvuloplasty with a new method
Date of disclosure of the study information 2013/05/01
Last modified on 2021/05/07

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Basic information
Public title Percutaneous transvenous aortic valvuloplasty with a new method
Acronym Percutaneous transvenous aortic valvuloplasty with a new method
Scientific Title Percutaneous transvenous aortic valvuloplasty with a new method
Scientific Title:Acronym Percutaneous transvenous aortic valvuloplasty with a new method
Region
Japan

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

Objectives
Narrative objectives1 To reveal the clinical outcome of percutaneous transvenous aortic valvuloplasty with a new method for aortic valve stenosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Technical success, Perioperative mortality, Incidence of complication
Key secondary outcomes Event free survival of total death, Aortic valve stenosis related death, Restenosis rate, Second intervention and surgical conversion

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 Inoue balloon catheter for aortic 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 are judged conventional surgery to replace the aortic valve is associated with high risk.
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 1.0 cm2 ( or effective orifice area index less than 0.6cm2/m2).
3. Heart failure symptoms with the NYHA classification greater than class II ( this shall not apply, patient have sudden death risk).
4.The patient agree to this trial with a written informed consent approved by the institutional review board.
5. The patient agree to participate in all follow-up examination after the procedure.
Key exclusion criteria 1. Acute myocardial infarction within 1 month.
2. Unicuspid aortic valve.
3. Severe aortic valve regurgitation.
4. Prior valve surgery.
5. Need of the emergency surgery by some kind of reasons why an aortic stenosis does not have relations.
6.Obstructive or nonobstructive cardiomyopathy.
7. Severe LV dysfunction (LVEF<20%).
8. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months.
9. Allergy to heparin.
10. CVA or TIA within 6 month.
11. Life expectancy less than 12 months due to non-cardiac disease.
12. Involvement in another clinical trial.
13. Allergy to latex.
14. Making the safe insertion of sheath introducer impossible by thrombosis from the common iliac vein through the femoral vein.
15. Cardiologist and cardiovascular surgeon decision not to register to this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Kimura
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code 6068507
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4254
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Naritatsu
Middle name
Last name Saito
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code 6068507
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4254
Homepage URL
Email naritatu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization PTMC institute
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kyoto University Hospital
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 Day

Related information
URL releasing protocol nasi
Publication of results Unpublished

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 2
Results N/A
Results date posted
2021 Year 05 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics N/A
Participant flow N/A
Adverse events N/A
Outcome measures N/A
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 04 Month 23 Day
Date of IRB
2013 Year 04 Month 23 Day
Anticipated trial start date
2013 Year 04 Month 23 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information The study is finished as scheduled.

Management information
Registered date
2013 Year 05 Month 01 Day
Last modified on
2021 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012371

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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