UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility study of a novel magnetocardiography for patients with intraventricular conduction disturbance.
Title of the study (Brief title)	The feasibility study of a novel magnetocardiography for patients with intraventricular conduction disturbance.
Region	Japan

Condition
Condition	intraventricular conduction disturbance
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Magnetocardiography for patients with intraventricular conduction disturbance is recorded by a novel magnetocardiography, and compare QRS complex of magnetocardiography with electrocardiography.
Basic objectives2	Others
Basic objectives -Others	In patients with ventricular conduction disturbance in the electrocardiogram, compare the waveform acquired by measurement of the magnetocardiogram with the waveform acquired by measurement of the 12-lead electrocardiogram. In the magnetocardiogram, evaluate whether QRS complex and QRS width similar to 12 lead ECG can be confirmed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In patients with ventricular conduction disturbance in the electrocardiogram, compare the waveform acquired by measurement of the magnetocardiogram with the waveform acquired by measurement of the 12-lead electrocardiogram. In the magnetocardiogram, evaluate whether QRS complex and QRS width similar to 12 lead ECG can be confirmed.
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
Key inclusion criteria	Patients with intraventricular conduction disturbance (QRS width> 120 ms) satisfying all the following criteria (1) Those who got adequate explanation about the purpose, details, expected effects of equipment and dangers of this examination, and obtained written informed consent. (2) Must be aged 20 years or older at the time of acquiring consent. (3) Those who can comply with the rules prescribed in the examination, receive examination and examination, and can report subjective symptoms etc.
Key exclusion criteria	1. past history of disease 2. subject joing the other study 3. patients with taking medicine for heart disease 4. patients with cardiac Implantable electronic device 5. past history of cardiac surgery 6. not suitable for this study
Target sample size	6

Research contact person
Name of lead principal investigator	KOJI FUKUZAWA
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Address	Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
TEL	078-382-5846
Email	kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person	KOJI FUKUZAWA
Organization	Kobe University Graduate School of Medicine
Division name	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine
Address	Kusunoki-Cho 7-5-2, Chuoh-Ku, Kobe, Japan
TEL	078-382-5846
Homepage URL
Email	kfuku@med.kobe-u.ac.jp

Sponsor
Institute	Section of Arrhythmia, Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	ADVANTEST
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2018 Year 11 Month 26 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 19 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2018 Year 11 Month 18 Day
Last modified on	2018 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039823