UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038498 |
|---|---|
| Receipt number | R000043867 |
| Scientific Title | Multicenter registry for treatment, prognosis of atrial fibrillation |
| Date of disclosure of the study information | 2019/11/05 |
| Last modified on | 2020/11/05 12:40:20 |
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Basic information
Public title
Multicenter registry for treatment, prognosis of atrial fibrillation
Acronym
Left atrial appendage closure registry
Scientific Title
Multicenter registry for treatment, prognosis of atrial fibrillation
Scientific Title:Acronym
Left atrial appendage closure registry
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We register the details of the LAAC procedure performed for patients with atrial fibrillation to clarify the outcomes and occurrence of adverse events related to the procedure.
Furthermore, we will elucidate what factors influence the prognosis and the adverse events after the procedure.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After the invasive procedure:
1. Perioperative period: in-hospital death, complication (myocardial infarction, cardiac tamponade, vascular accident, cerebral infarction, bleeding for needing blood transfusion)
2. Follow-up 1year, 2year, 3year, 4year, 5year after procedure: presence or absence of admission of heart failure, presence or absence of the death (cardiovascular death, non-cardiovascular death), presence or absence of stroke, presence or absence of bleeding
Key secondary outcomes
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
The patients with atrial fibrillation who undergo left atrial appendage closure
Key exclusion criteria
The patients who are under the 20 years old or who are found unfit to be respondent to a survey by physician-in-charge
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Hayashida |
Organization
Keio University Hospital
Division name
Department of Cardiology
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5843-6702
k-hayashida@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Hayashida |
Organization
Keio University Hospital
Division name
Department of Cardiology
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5843-6702
Homepage URL
k-hayashida@umin.ac.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital Clinical and Translational Research Center
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
Tel
03-5363-3961
med-rinri-jimu@adst.keio.ac.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
| 2019 | Year | 11 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: An observational study
Way for subscription: Explain the content of this research verbally using an explanatory document and obtain consent to participate in this research. We present a information of study implementation and Opt-out document about this clinical research to Keio University Hospital Website, Clinical Research Promotion Center Website and Cardiovascular Internal Medicine Website, and we release the content of this study implementation. We give an Opt-out document to such patients needs in any way. The cases of the patient who refuse registration, we indicate so on the clinical record and we don't collect information.
Term of registration: 5-years
Management information
Registered date
| 2019 | Year | 11 | Month | 05 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043867
