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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031652
Receipt No. R000034688
Scientific Title Prospective comparison of porcine pericardial prostheses in patients with severe aortic stenosis and reduced cardiac function
Date of disclosure of the study information 2018/03/09
Last modified on 2018/03/09

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Basic information
Public title Prospective comparison of porcine pericardial prostheses in patients with severe aortic stenosis and reduced cardiac function
Acronym J-league trial
Scientific Title Prospective comparison of porcine pericardial prostheses in patients with severe aortic stenosis and reduced cardiac function
Scientific Title:Acronym J-league trial
Region
Japan

Condition
Condition aortic stenosis
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of hemodynamics between inner- and outer-mounted pericardial valves
Basic objectives2 Others
Basic objectives -Others Survival and freedom from valve related complications
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peak pressure gradient at 1 years after implantation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Trifecta valve 50 cases
Interventions/Control_2 Magna valve 50 cases
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
60 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1,Low ejection fraction (<50%) on preoperative echocardiography
2. Surgical aortic valve replacement without prior pericardiotomy and catheter aortic valve intervention
3. Including concomitant coronary artery bypass, ascending aortic replacement, and tricuspid annuloplasty
4. Severe aortic stenosis (preoperative peak pressure gradient >64mmHg, mean pressure gradient >40mmHg, or aortic valve area <1.0 cm2)
5. Planned implanted valve size is 19-21mm (Annulus diameter <21mm on preoperative echocardiography)
Key exclusion criteria 1. concomitant mitral valve surgery
2. Aortic root replacement
3. age < 60 years
4. Patients with no preoperative echocardiography data
5. emergency surgery
6. Chronic hemodialysis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Okita
Organization Kobe University, graduate school of medicine, Department of Surgery
Division name Division of Cardiovascular Surgery
Zip code
Address 7-5-1, Kusunokicho, Chuoku, Kobe
TEL 0783825942
Email yutakaokita@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Tanaka
Organization Kobe University, graduate school of medicine, Department of Surgery
Division name Division of Cardiovascular Surgery
Zip code
Address 7-5-1, Kusunokicho, Chuoku, Kobe
TEL 0783825942
Homepage URL
Email hirtanak@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization St. Jude Medical
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 09 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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
2018 Year 03 Month 09 Day
Last modified on
2018 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034688

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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