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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | aortic stenosis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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) |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |