UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of Ventricular Fibrillation via the Left Ventricular Lead Implanted for Resynchronization Therapy
Title of the study (Brief title)	Detection of Ventricular Fibrillation via the Left Ventricular Lead
Region	Japan

Condition
Condition	chronic heart failure, ventricular fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate equivalence in detection of ventricular fibrillation on implantable cardioveter defibrillator between the left ventricular lead and the right ventricular lead
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	equivalece in detection of ventricular fibrillation between the left ventricular lead and the right ventricular lead
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	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	recording of the intracardiac electrocardiogram via the left ventricular lead at the defibrillation test
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	1. All subjects must give the agreement for implantation or replacement of implantable resynchronization therapy defibrillator in writing.
Key exclusion criteria	1.patients who cannot give the informed consent. 2.patients who do not fit the clinical indication for defibrillation test. 3. patients who are implanted with the unipolar left ventricular lead or more suitable for the unipolar LV lead than the bipolar LV lead. 4.patients implanted with a CRTD using significantly different filter for VF detection from that of a test ICD or a new CRTD.
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshio Kobayashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Science and Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260–8670, Japan
TEL
Email

Public contact
Name of contact person	Marehiko Ueda
Organization	Chiba University Hospital
Division name	Department of Cardiology
Address
TEL
Homepage URL
Email	zta10540@nifty.com

Sponsor
Institute	Chiba University Graduate School of Medicine Department of Cardiovascular Science and Medicine
Institute
Department

Funding Source
Organization	any organizations do not give specific fund for this study
Organization
Division
Category of Funding Organization	Other
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	2012 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 01 Day
Anticipated trial start date	2012 Year 08 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

Management information
Registered date	2012 Year 08 Month 26 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010309