UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031652 |
|---|---|
| Receipt number | 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 14:31:28 |
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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
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
hirtanak@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034688
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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