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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000001640 |
Receipt No. | R000001972 |
Scientific Title | Long-term results of SJM mechanical valve |
Date of disclosure of the study information | 2009/01/16 |
Last modified on | 2011/07/16 |
Basic information | ||
Public title | Long-term results of SJM mechanical valve | |
Acronym | Long-term results of SJM mechanical valve | |
Scientific Title | Long-term results of SJM mechanical valve | |
Scientific Title:Acronym | Long-term results of SJM mechanical valve | |
Region |
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Condition | ||
Condition | Patients of valve replacement using ATS mechanical valve | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This research has aimed to evaluate the long-term result of SJM mechanical valve. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | valve-related complication |
Key secondary outcomes | mortality, cause of death, echocardiograhic data,LDH |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | valve disease | |||
Key exclusion criteria | none | |||
Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nihon University Itabashi Hosipial | ||||||
Division name | Department of Cardiovascular Surgery | ||||||
Zip code | |||||||
Address | 30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo | ||||||
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Organization | Nihon University school of medicine | ||||||
Division name | Department of Cardiovascular Surgery | ||||||
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Sponsor | |
Institute | Nihon University School of Medicine |
Institute | |
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Funding Source | |
Organization | self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | retrospecive study |
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=R000001972 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |