UMIN-CTR Clinical Trial

Basic information
Public title	Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Acronym	Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Scientific Title	Validation of Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Scientific Title:Acronym	Arrhythmia Diagnosis using Wrist Watch type Pulse wave machine.
Region	Japan

Condition
Condition	Atrial Fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the validation of arrhythmic diagnosis using wrist watch type pulse wave monitoring
Basic objectives2	Others
Basic objectives -Others	Validation of arrhythmia diagnosis
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic rate sensitivity, specificity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	arrhythmia diagnosis by pulse wave
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Atrial Fibrillation
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Kusano
Organization	National Cerebral and Cardiovascular Center
Division name	Cardiovascular Medicine
Zip code	564-8565
Address	6-1Kishibeshinmachi,Suita,Osaka
TEL	+81661701070
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	Cardiovascular Medicine
Zip code	564-8565
Address	6-1Kishibeshinmachi,Suita,Osaka
TEL	+81661701070
Homepage URL
Email	kusanokengo@hotmail.com

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Committee
Address	6-1Kishibeshinmachi,Suita,Osaka
Tel	+81661701070
Email	rec-office-ac@ncvc.go.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	2016 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	136
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	Completed
Date of protocol fixation	2015 Year 04 Month 30 Day
Date of IRB	2015 Year 02 Month 23 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 03 Day
Last modified on	2020 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024003