UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043867