UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter survey of the idiopathic ventricular fibrillation
Acronym	Multicenter survey of the idiopathic ventricular fibrillation
Scientific Title	Multicenter survey of the idiopathic ventricular fibrillation
Scientific Title:Acronym	Multicenter survey of the idiopathic ventricular fibrillation
Region	Japan

Condition
Condition	Idiopathic ventricular fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purposes of this study are to investigate the clinical characteristics and prognosis of patients with idiopathic ventricular fibrillation (Brugada syndrome, early repolarization syndrome, idiopathic ventricular fibrillation of unknown etioloty) in a prospective manner.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between clinical characteristics and prognosis in patients with idiopathic ventricular fibrillation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with idiopathic ventricular fibrillation (Brugada syndrome, early repolarization syndrome, idiopathic ventricular fibrillation of unknown etiology)
Key exclusion criteria	none
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Kusano
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cardiovascular medicine
Zip code	564-8565
Address	6-1, Kishibeshinmachi, Suita, Osaka
TEL	06-6170-1070
Email	kusanokengo@hotmail.com

Public contact
Name of contact person	1st name Kengo Middle name Last name Kusano
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Cardiovascular medicine
Zip code	564-8565
Address	6-1, Kishibeshinmachi, Suita, Osaka
TEL	06-6170-1070
Homepage URL
Email	kusanokengo@hotmail.com

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	a grant from Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cerebral and Cardiovascular Center
Address	6-1, Kishibeshinmachi, Suita, Osaka
Tel	06-6170-1070
Email	kusanokengo@hotmail.com

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	2016 Year 07 Month 11 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	2016 Year 01 Month 09 Day
Date of IRB	2016 Year 03 Month 23 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a multicenter prospective study. We are going to evaluate the clinical characteristics and prognosis of patients with idiopathic ventricular fibrillation and an implantable cardioverter defibrillator.

Management information
Registered date	2016 Year 07 Month 11 Day
Last modified on	2022 Year 01 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026654