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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038498
Receipt No. R000043867
Scientific Title Multicenter registry for treatment, prognosis of atrial fibrillation
Date of disclosure of the study information 2019/11/05
Last modified on 2019/11/05

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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
Email 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
Email k-hayashida@umin.ac.jp

Sponsor
Institute Keio University Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 05 Day
Date of IRB
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
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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