UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010629 |
|---|---|
| Receipt number | 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 14:29:26 |
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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
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
naritatu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012371
