UMIN-CTR Clinical Trial

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