UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045894 |
|---|---|
| Receipt number | R000052392 |
| Scientific Title | Left Atrial appendage closure: Compare with AtriClip vs Appendage resection |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2021/10/28 10:58:17 |
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Basic information
Public title
Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Acronym
Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Scientific Title
Left Atrial appendage closure: Compare with AtriClip vs Appendage resection
Scientific Title:Acronym
Compare with AtriClip vs Appendage resection
Region
| Japan |
Condition
Condition
Atrial fiblliation cardiacsurgery left appendage operation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we compare the residual left atrial appendage lumen (stump formation) between epicardial clip (AtriClip) and appendage resection, and the early and mid-term results of each technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
stroke incidents caused by cardiogenic thrombus
Key secondary outcomes
reoperation or death.
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
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
AtriClip
Resection
Key exclusion criteria
ligation
internal suture closure
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Cardiovascular and Respiratory Center
Division name
Cardiac surgery
Zip code
360-0197
Address
1696,Itai
TEL
+81485369900
cardiacsurgken@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Cardiovascular and Respiratory Center
Division name
Cardiac surgery
Zip code
360-0197
Address
1696, Itai, Kumagayashi,Saitama
TEL
0485369900
Homepage URL
cardiacsurgken@ybb.ne.jp
Sponsor or person
Institute
Saitama Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board at the Saitama Cardiovascular and Respiratory Center (No. 2021032).
Address
169, Itai, Kumagayashi,Saitama
Tel
+81485369900
cardiacsurgken@ybb.ne.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052392
